MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF AXS VECTA 071 CATH 132CM - US; CATHETER, THROMBUS RETRIEVER

Catalog Number INC-11129-132

Device Problems Fracture (1260); Material Puncture/Hole (1504)

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

Event Date 10/30/2023

Event Type  malfunction  

Event Description

It was reported that during a thrombus retrieval procedure, while attempting to guide the subject intermediate catheter with microcatheter and guidewire, resistance was encountered.It was seen that guidewire was able to advance but microcatheter was stuck in subject intermediate catheter.When tried with different guidewire, it deviated from the tip of subject intermediate catheter.Operator removed the subject intermediate catheter and its shaft was found broken and perforated.The operator replaced it with a new device and continued the procedure without clinical consequences to the patient.

Manufacturer Narrative

H3 other text : the device is not available to the manufacturer.

Event Description

It was reported that during a thrombus retrieval procedure, while attempting to guide the subject intermediate catheter with microcatheter and guidewire, resistance was encountered.It was seen that guidewire was able to advance but microcatheter was stuck in subject intermediate catheter.When tried with different guidewire, it deviated from the tip of subject intermediate catheter.Operator removed the subject intermediate catheter and its shaft was found broken and perforated.The operator replaced it with a new device and continued the procedure without clinical consequences to the patient.

Manufacturer Narrative

There are controls in the manufacturing process to ensure the product met specifications upon release.During visual and microscopic inspection, it was observed that the subject catheter shaft was seen to be flat/crushed at 14.5 cm from the hub and kinked/bent at 27.5 and 118 cm.The catheter hub and tip were intact and no fracture or perforation was noted.Functional testing was not carried out due to the damage noted to the subject catheter.The subject catheter was flushed without difficulties no leaks were noted.The reported event is covered in the device direction for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported catheter shaft friction could not be duplicated during device analysis; however, the analysis results are consistent with the reported event.The reported catheter shaft broken/fractured during use and catheter shaft has hole/perforation were not confirmed during the analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The subject catheter shaft was seen to be flat/crushed and kinked/bent.No fracture or hole/perforation was noted on the catheter during analysis.The catheter tip and hub, both were found to be intact.The as reported code, 'catheter shaft friction' as well as the as analysed codes, 'catheter shaft kinked/bent' and 'catheter shat flat/crushed' will be assigned procedural factors.This complaint appears to be associated with a product that met design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.An assignable cause of 'not confirmed' was assigned to the as reported codes 'catheter shaft broken/fractured during use' and 'catheter shaft has hole/perforation' as the issue included a returned product review (visual, physical, and/or performance testing) which showed no evidence of either the alleged issue(s) or any defect which could have contributed to the event.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• Brand Name: AXS VECTA 071 CATH 132CM - US
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• Manufacturer (Section G): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 18203405
• MDR Text Key: 328901181
• Report Number: 3008853977-2023-00043
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: INC-11129-132
• Device Lot Number: 18572-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2023
• Initial Date FDA Received: 11/24/2023
• Supplement Dates Manufacturer Received: 01/31/2024
• Supplement Dates FDA Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2021
• 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
• Treatment: CHIKAI-14 GUIDEWIRE (ASAHI).; OPTIMO BALLOON GUIDE CATHETER (TOKAI MEDICAL).; RADIOFOCUS GUIDEWIRE (TERUMO).; TRAK 21 MICROCATHETER (STRYKER).