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

Catalog Number IC71132CA

Device Problem Material Twisted/Bent (2981)

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

Event Date 03/15/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Section e.1: the name, phone and email address of the initial reporter are not available / reported.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 132cm embovac 71 aspiration catheter was received contained in the decontamination pouch.Visual inspection was performed.The hydrophilic coating was confirmed to be present.One kink was found on the proximal end of the device (at 94 cm distally).It was also noted that the shaft has compression and stretching damage at 21cm to 33 cm from the distal end; in addition, it was noted that as a result of this stretching, the internal braided mesh is exposed in multiple sections.Microscopic inspection was performed.Under magnification, it was noted that the plastic layer has elongated areas where the plastic is no longer able to be continuously covering the braided mesh below on the proximal aspect of the device.The integrity of the distal braided mesh was not compromised.The inner diameter (id) and outer diameter (od) of the intermediate area and the proximal side of the returned embovac catheter were within the specification range.The issue reported in the complaint that the embovac catheter was kinked was confirmed based on the kinked condition observed on the returned device; however, factors not described in the information provided, such as patient anatomy, device manipulation, and operator¿s technique, may have contributed to the issue encountered.According to the risk documentation, anatomical tortuosity, no inspection, and continuing to use a damaged catheter are potential causes of failure for catheter damage.There is no indication that the issue reported in the complaint results from a defect inherently related to the device.The rest of the damages found on the returned device were not reported as such, and the exact time when these conditions appeared cannot be determined based on the information available; however, these are suspected to be the result of the manipulation required during the device's removal and are not considered related to the event reported.The stretched and compressed conditions suggested that there was excessive pulling load applied to the damaged area during the attempt of withdrawal.A review of manufacturing documentation associated with this lot (30885289) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at different points during the manufacturing process to prevent damages such as catheter stretching and kinking from leaving the facility.It should be noted that product failure could be caused by multiple factors.The instruction for use (ifu) contains the following precaution: exercise care in handling the embovac catheter to reduce the chance of accidental damage.Based on the manufacturing documentation 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.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.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 during a procedure targeting an ischemic stroke, the complaint device, a 132cm embovac 71 aspiration catheter (ic71132ca / 30885289) was used and it was kinked during the case.The physician used a ¿same -like¿ product and the procedure was successfully completed.There was no report of negative patient impact.Multiple attempts to obtain additional information related to the procedure and the reported device issue were unsuccessful.If additional information is received at a later date, this file will be updated accordingly.The complaint device was returned for evaluation and analysis.Based on the result of the product analysis completed on (b)(6) 2023, the reported issue meets usfda reporting criteria under 21 cfr 803 as a "malfunction.".

• 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
• Manufacturer (Section G): CODMAN AND SHURTLEFF INC. (MIRAMAR); 3260 executive way; miramar FL 33025
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 17195608
• MDR Text Key: 318213951
• Report Number: 3008114965-2023-00412
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: IC71132CA
• Device Lot Number: 30885289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1