MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 125CM EMBOVAC 71 ASP. CATHETER; EMBOVAC ASPIRATION CATHETER

Catalog Number IC71125CA

Device Problems Difficult to Remove (1528); Stretched (1601)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No.: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.The product lot number is not available / not reported.The expiration date of the device is not known.The initial reporter first name, phone, and email address are not available / reported.The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.The device manufacture date is not known as the product lot number of the device is not available / not reported.The photos that were included in the complaint underwent review by the product analysis team.The following is the photo assessment: based on the photos, the complaint device was outside of its original packaging.It can be observed that the 125cm embovac 71 aspiration catheter has a compressed area and the distal tip is in elongated condition.The photos only captured the distal tip.Based on the photos, the reported difficulty in removal (withdrawal) can be confirmed based on the elongated condition observed.Further investigation will be performed once the device is returned for evaluation and analysis.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Event Description

The healthcare professional reported that during a thrombectomy procedure, the physician reported that he had good technical success with good performance of the device using the 125cm embovac 71 aspiration catheter (ic71125ca / lot# unknown), but there was difficulty during removal and obvious damage on some of its routes.It appears that this problem has had no repercussions for the patient.The procedure was successfully completed.There was no report of any patient adverse event or complication.Photos of the complaint device were included in the complaint.Additional event information was received on 25 january 2021.The procedure was targeting an occlusion at the right middle cerebral artery (mca); the vessel did not show tortuosity or associated pathologies, it did not have any excessively tortuous or acute bends.Continuous flush had been maintained through the catheter.The physician used a rebar¿ 18 microcatheter (medtronic), synchro¿ guidewire (stryker), a catch device (balt), and a stent retriever (unknown brand).There was no device malfunctions or performance issues associated with the concomitant devices that were used with the embovac that may have contributed to the difficulty in removal issue reported.There was no delay in the procedure as the issue occurred when the catheter was being removed.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on (b)(6) 2021.A supplemental 3500a report will be submitted once the product investigation has been completed.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the complaint product is no longer available to be returned for evaluation and analysis.[conclusion]: the healthcare professional reported that during a thrombectomy procedure, the physician reported that he had good technical success with good performance of the device using the 125cm embovac 71 aspiration catheter (ic71125ca / lot# unknown), but there was difficulty during removal and obvious damage on some of its routes.It appears that this problem has had no repercussions for the patient.The procedure was successfully completed.There was no report of any patient adverse event or complication.Photos of the complaint device were included in the complaint.Additional event information was received on 25 january 2021.The procedure was targeting an occlusion at the right middle cerebral artery (mca); the vessel did not show tortuosity or associated pathologies, it did not have any excessively tortuous or acute bends.Continuous flush had been maintained through the catheter.The physician used a rebar¿ 18 microcatheter (medtronic), synchro¿ guidewire (stryker), a catch device (balt), and a stent retriever (unknown brand).There was no device malfunctions or performance issues associated with the concomitant devices that were used with the embovac that may have contributed to the difficulty in removal issue reported.There was no delay in the procedure as the issue occurred when the catheter was being removed.Based on complaint information, the device was not available to be returned for analysis.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.Product evaluation and analysis cannot be conducted as the product was not available to be returned.Determination of causes and possible contributing factors could not be made.As such, the investigation will be closed.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed through functional evaluation and analysis.The photos that were included in the complaint underwent review by the product analysis team.The following is the photo assessment: based on the photos, the complaint device was outside of its original packaging.It can be observed that the 125cm embovac 71 aspiration catheter has a compressed area and the distal tip is in elongated condition.The photos only captured the distal tip.Based on the photos, the reported difficulty in removal (withdrawal) can be confirmed based on the elongated condition observed.The lot number of the device is not known, therefore review of the device history record was not performed.The exact cause of the event could not be conclusively determined; however, it is possible that circumstances of the procedure and / or device manipulation / interaction may have contributed to the reported failure.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during a thrombectomy procedure, the physician reported that he had good technical success with good performance of the device using the 125cm embovac 71 aspiration catheter (ic71125ca / lot# unknown), but there was difficulty during removal and obvious damage on some of its routes.It appears that this problem has had no repercussions for the patient.The procedure was successfully completed.There was no report of any patient adverse event or complication.Photos of the complaint device were included in the complaint.Additional event information was received on 25 january 2021.The procedure was targeting an occlusion at the right middle cerebral artery (mca); the vessel did not show tortuosity or associated pathologies, it did not have any excessively tortuous or acute bends.Continuous flush had been maintained through the catheter.The physician used a rebar¿ 18 microcatheter (medtronic), synchro¿ guidewire (stryker), a catch device (balt), and a stent retriever (unknown brand).There was no device malfunctions or performance issues associated with the concomitant devices that were used with the embovac that may have contributed to the difficulty in removal issue reported.There was no delay in the procedure as the issue occurred when the catheter was being removed.The device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 125cm embovac 71 aspiration catheter was received contained in a pouch.Visual inspection was performed.The returned device was observed compressed and slightly stretched from 118 cm to 120 cm from the proximal end.No other damage was observed during the visual inspection.This is consistent with the photos that were included in the complaint and were reviewed by the product analysis team.Dimensional measurements were taken.The inner diameter (id) and outer diameter (od) of the device were measured and were found to be within specification.Hub id = 0.0715 inch; specification: 0.071 inch minimum.Distal id = 0.0715 inch; specification: 0.071 inch minimum.Actual microcatheter od = 0.0829 inch; specification: max.0.0837 inch / min.0.081 inch.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.The complaint reported that the physician reported good technical success with good device performance when he used the 125cm embovac 71 aspiration catheter during the thrombectomy procedure.However, there was difficulty during removal and obvious damage on some of its route.Visual inspection / analysis of the complaint device noted that the device was compressed and was slightly stretched.The issue reported was confirmed.The observed condition is most likely a result of force exerted on the device during handling; the exact cause cannot be conclusively determined.Dimensional analysis confirmed that the id and od of the device met specification, however, functional testing was not performed as the reported withdrawal difficulty is specific to and depended on the patient anatomy and procedure device handling.The product analysis lab cannot replicate the same environment as during the procedure.Though the compressed and stretched condition of the device are likely the results of the issue related to device withdrawal where force may have been inadvertently applied during the attempt to retract / withdraw the device.It should be noted that product failure is multifactorial.Although no conclusion could be reached on the cause of the reported event, the instructions for use contain the following precautions: carefully inspect all devices prior to use.Verify size, length, and condition are suitable for the specific procedure.Do not use a device that has been damaged in any way; replace with another large bore catheter.A damaged device may cause complications.Exercise care in handling the large bore catheter to reduce the chance of accidental damage.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.H.6: investigation findings / investigation conclusions: the ¿no device problem found¿ code was used in the investigation findings because the reported issue related to the withdrawal difficulty could not be duplicated in the product analysis lab as the issue is specific to and depended on the patient anatomy and procedure device handling.The product analysis lab cannot replicate the same environment as during the procedure.This code corresponds to the code ¿cause not established¿ code in the investigation conclusions.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: 125CM EMBOVAC 71 ASP. CATHETER
• Type of Device: EMBOVAC ASPIRATION CATHETER
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 11259578
• MDR Text Key: 231943994
• Report Number: 3008114965-2021-00029
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IC71125CA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Date Manufacturer Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CATCH DEVICE (BALT); REBAR¿ 18 MICROCATHETER (MEDTRONIC); STENT RETRIEVER (UNKNOWN BRAND); SYNCHRO¿ GUIDEWIRE (STRYKER)