MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL 132CM EMBOVAC 71 ASP. CATHETER; EMBOVAC ASPIRATION CATHETER

Catalog Number IC71132CA

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

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

Event Date 09/06/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.The expiration date of the device is not known as the device lot number is not available / not reported.The name, phone and email address of the initial reporter 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 device lot number is not available / not reported.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 the thrombectomy procedure targeting a lesion on the m1, a 132cm embovac 71 aspiration catheter (ic71132ca / lot# unknown) was raised to the m1; there was no problem with follow-up or suction, but when the embovac catheter was inserted again to attempt the second pass on the residual distal lesion, it was confirmed that there was an air leak through a small hole in the catheter.It was reported that the broken part may have been at the point where the color of the proximal part changes.The physician stopped using the device.The concomitant devices used were the 9f optimo¿ balloon guide catheter (tokai) and the trevo trak 21 microcatheter (stryker).There was no report of any patient adverse event or complication.

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 15-oct-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 include the additional event information received on 14-oct-2021.[additional information]: the healthcare professional reported that during the thrombectomy procedure targeting a lesion on the m1, a 132cm embovac 71 aspiration catheter (ic71132ca / lot# unknown) was raised to the m1; there was no problem with follow-up or suction, but when the embovac catheter was inserted again to attempt the second pass on the residual distal lesion, it was confirmed that there was an air leak through a small hole in the catheter.It was reported that the broken part may have been at the point where the color of the proximal part changes.The physician stopped using the device.The concomitant devices used were the 9f optimo¿ balloon guide catheter (tokai) and the trevo trak 21 microcatheter (stryker).There was no report of any patient adverse event or complication.On 14-oct-2021, additional information was provided.The information confirmed that the reported event did not result in any patient injury or complication; additional intervention was not required.There was no blood flow restriction / reduction as a result of the issue reported.There was no procedure prolongation nor any clinically significant procedure delay.No resistance was reported at any point while the embovac catheter was in use.Photos of the device are not available.The embovac catheter was used and prepped in accordance with the instructions for use (ifu).Excessive force was not applied to the device.E.1: the initial reporter phone: (b)(6) 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 the thrombectomy procedure targeting a lesion on the m1, a 132cm embovac 71 aspiration catheter (ic71132ca / lot# unknown) was raised to the m1; there was no problem with follow-up or suction, but when the embovac catheter was inserted again to attempt the second pass on the residual distal lesion, it was confirmed that there was an air leak through a small hole in the catheter.It was reported that the broken part may have been at the point where the color of the proximal part changes.The physician stopped using the device.The concomitant devices used were the 9f optimo¿ balloon guide catheter (tokai) and the trevo trak 21 microcatheter (stryker).There was no report of any patient adverse event or complication.On 14-oct-2021, additional information was provided.The information confirmed that the reported event did not result in any patient injury or complication; additional intervention was not required.There was no blood flow restriction / reduction as a result of the issue reported.There was no procedure prolongation nor any clinically significant procedure delay.No resistance was reported at any point while the embovac catheter was in use.Photos of the device are not available.The embovac catheter was used and prepped in accordance with the instructions for use (ifu).Excessive force was not applied to the device.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 132cm embovac 71 aspiration catheter was returned contained in a pouch.Visual inspection was performed.It was observed that the device is fractured near the id band.It was also observed to be kinked at 7 inches, 11 inches, and 23 inches from the proximal end.A compressed area was observed at 46 inches from the proximal end.No other damages nor anomalies were observed during the visual inspection.Dimensional evaluation: the inner diameter (id) and outer diameter (od) were measured and confirmed 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 = 0.0827 inch; specification: max.0.0837 inch / min.0.081 inch.Due to the condition of the returned device, functional test could not be performed.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.The complaint documented that the 132cm embovac 71 aspiration catheter was used during the thrombectomy procedure; it was raised to the m1 segment and there was no problem with follow-up or suction, but when the device was inserted again in attempt at a second pass on the residual distal lesion, it was confirmed that there was an air leak through a small hole in the catheter.The broken part was reported as may have been at the point where the color of the proximal part changes.The device was returned and during visual inspection, it was noted to be fractured near the id band.There are kinks at several areas on the body and one compressed area.Based on the observations made during the visual inspection, the reported issue was confirmed.Procedural handling and other factors may have been possible causes of the issue reported.The exact cause cannot be conclusively determined.It should be noted that product failure is multifactorial.The instructions for use (ifu) contains the following precaution: ¿ 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.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.

• Brand Name: 132CM 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: 12529937
• MDR Text Key: 280536475
• Report Number: 3008114965-2021-00448
• 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: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IC71132CA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2021
• Date Manufacturer Received: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 9F OPTIMO¿ BALLOON GUIDE CATHETER (TOKAI); TREVO TRAK 21 MICROCATHETER (STRYKER)