MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF AXS VECTA 074 CATH 132CM - US; CATHETER, THROMBUS RETRIEVER

Catalog Number INC-11597-132

Device Problem Fracture (1260)

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

Event Date 06/04/2023

Event Type  malfunction  

Event Description

Analysis of the returned device found that the subject catheter tip was broken/ fractured during use.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully.

Manufacturer Narrative

Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During the visual inspection, the catheter shaft was seen to be kinked/bent and flat/crushed from the catheter hub.The catheter tip was seen to be broken/fractured and the inner coil was seen to be exposed.The distal catheter shaft was seen to be stretched.There was a dried blood noted in the catheter hub and in the catheter shaft.Functional inspection was not carried out due to the damage noted to the device.The reported event is covered in the device directions 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 catheter tip broken/fractured during prep was not confirmed during analysis.The reported event catheter shaft difficulty removing/withdrawing could not be replicated during device analysis; however, the analysis results are consistent with the reported event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The device was returned for analysis and the catheter shaft was seen to be kinked/bent and flat/crushed.The catheter tip was seen to be broken/fractured and the inner coil was seen to be exposed.The distal catheter shaft was seen to be stretched.There was a dried blood noted in the catheter hub and in the catheter shaft.The presence of dried blood in the hub is an indication that insufficient flush might have been a factor in this complaint.Additional information provided by the customer indicated that resistance was felt when removing the subject catheter from within the guide catheter.The resistance was felt within the rhv that was connected to the guide catheter.They removed the rhv with the subject catheter still inside of the rhv.Once removed, they then pulled subject catheter out of the rhv on the back table and at that point the distal tip of subject catheter fracture.On the table.Not in the patient.There is possibility that the tip of the catheter broke while retracting the subject catheter out of the guide catheter and was only noticed once it was completely out on the back table.This complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.Therefore, an assignable cause of procedural factors will assigned to as analyzed code catheter shaft kinked/bent, catheter shaft flat/crushed, catheter shaft stretched and catheter tip broken/fractured during use and as reported code catheter shaft difficulty removing/withdrawing.An assignable cause of 'not confirmed' was assigned to the as reported defect catheter tip broken/fractured during preparation 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.

• Brand Name: AXS VECTA 074 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: 17866139
• MDR Text Key: 325074575
• Report Number: 3008853977-2023-00039
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 07613327459265
• UDI-Public: 07613327459265
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 10/03/2023

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-11597-132
• Device Lot Number: 20160-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2022
• 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
• Treatment: BMX 96 GUIDE CATHETER (PENUMBRA).
• Patient Sex: Male