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

Catalog Number IC71132CA

Device Problems Difficult to Remove (1528); Material Twisted/Bent (2981)

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

Event Date 05/01/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient date of birth, weight, race, ethnicity, and medical history were not provided.The initial reporter 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.A review of manufacturing documentation associated with this lot (30411994) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.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 procedure, after using the 132cm embovac 71 aspiration catheter (ic71132ca / 30411994), when the physician removed the embovac from the patient, she saw that it kinked and was ruined.There was no additional intervention required to remove the device.There was no break in the device; it was still intact.The device had been advanced and withdrawn against resistance because it was jammed with the clots.It was reported that the resistance was encountered during the withdrawal from the vessel.There was no difficulty tracking the device to the target vessel.The device was prepped and used in accordance with the instructions for use (ifu) with adequate flush maintained through the device.Force was applied to the device but it was ¿not too much.¿ another catheter was used to continue with the procedure that was reported to have been successfully completed.All concomitant devices functioned as expected.The reported issue resulted in a maximum of two-minute delay that was not clinically significant.There was no report of any patient adverse event or complication as a result of the reported issue.Additional information was received on 09 may 2021 indicating that this was not an adapt (direct aspiration first pass technique) case.The physician does not perform snaking (advanced the catheter without a guidewire / microcatheter).

Manufacturer Narrative

Manufacturer¿s ref.No: pc-(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 procedure, after using the 132cm embovac 71 aspiration catheter (ic71132ca / 30411994), when the physician removed the embovac from the patient, she saw that it kinked and was ruined.There was no additional intervention required to remove the device.There was no break in the device; it was still intact.The device had been advanced and withdrawn against resistance because it was jammed with the clots.It was reported that the resistance was encountered during the withdrawal from the vessel.There was no difficulty tracking the device to the target vessel.The device was prepped and used in accordance with the instructions for use (ifu) with adequate flush maintained through the device.Force was applied to the device but it was ¿not too much.¿ another catheter was used to continue with the procedure that was reported to have been successfully completed.All concomitant devices functioned as expected.The reported issue resulted in a maximum of two-minute delay that was not clinically significant.There was no report of any patient adverse event or complication as a result of the reported issue.Additional information was received on 09 may 2021 indicating that this was not an adapt (direct aspiration first pass technique) case.The physician does not perform snaking (advanced the catheter without a guidewire / microcatheter).The device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 132cm embovac 71 aspiration catheter was received contained in a pouch.Visual inspection was performed.The returned device was observed kinked at 14 inches from the proximal end.The braided mesh was observed to be compressed.No other damages nor anomalies were observed.Dimensional analysis: the inner diameter (id) and outer diameter (od) of the device 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¿ minimum actual microcatheter od = 0.0831 inch; specification: max.0.0837 inch / min.0.081 inch.A review of manufacturing documentation associated with this lot (30411994) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.The complaint reported that during the procedure, after using the 132cm embovac 71 aspiration catheter, when the physician removed the embovac from the patient, she saw that it kinked and was ruined.Visual inspection of the returned device observed the kinked condition and the compressed area in the braided mesh.This confirmed the reported issue documented in the complaint.The dimensions of the returned device was measured and found to be within specification.The reported issue that the device encountered resistance during the attempt to withdraw it from the vessel could not be confirmed through functional evaluation as this is dependent on and specific to the patient anatomy and to the procedure at the time of the occurrence.The environment in the lab cannot replicate the condition to test for this issue.The compressed condition on the braided mesh may be the result of the difficulty during withdrawal from the vessel.Based on this compressed condition of the braided mesh, the issue was confirmed.It should be noted that product failure is multifactorial.Although no conclusion could be reach on the cause of the reported event, the instructions for use (ifu) contains the following precaution: ¿ exercise care in handling the large bore catheter to reduce the chance of accidental damage.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.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: the investigation findings code of ¿no device problem found (c19)¿ is related to the reported withdrawal difficulty from vessel / difficult to remove (a150207).The issue could not be duplicated in the laboratory setting as it is dependent on and specific to the patient anatomy at the time of occurrence.Updated sections: g.3, g.6.H.2, h.3, h.6, and h.10.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: pc-(b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on 28 may 2021.A supplemental 3500a report will be submitted once the product investigation has been completed.Updated sections: d.9, g.3, g.6.H.2, h.3, h.6, and h.10.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: 11865725
• MDR Text Key: 252924498
• Report Number: 3008114965-2021-00187
• 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
• Report Date: 05/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: IC71132CA
• Device Lot Number: 30411994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Date Manufacturer Received: 05/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1