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

Model Number	INC-11597-132
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacture.
Event or Problem Description
It was reported during aspiration with the pump when the subject catheter was retracted, there was severe resistance.After removing the catheter from the patient, the tip of the device was found fractured.The device was replaced and the procedure was completed successfully with no clinical consequences to the patient.
Event or Problem Description
It was reported during aspiration with the pump when the subject catheter was retracted, there was severe resistance.After removing the catheter from the patient, the tip of the device was found fractured.The device was replaced and the procedure was completed successfully with no clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the catheter shaft was seen to be stretched from 6cm to 10cm from the distal tip, was seen to be flat in several areas, and the catheter tip was seen to be flat.Functional inspection was not carried out due to the condition of the returned 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 reported event was not confirmed during analysis as no breaks were present anywhere on the catheter and functional inspection was not carried out due to condition of device.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that there was no damage noted to the packaging prior to preparation of the device, there were no anomalies noted to the device after removal from the packaging or prior to preparation and the device was prepared as per the dfu.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 the analyzed defect of the catheter shaft stretched, catheter shaft flat/crushed and catheter tip flat/crushed.An assignable cause of 'not confirmed' was assigned to the reported defect of the catheter tip broken/fractured during use and the catheter shaft difficulty removing/withdrawing 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 074 CATH 132CM - US
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork CA NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork CA NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 15468664
• Report Number: 3008853977-2022-00046
• Device Sequence Number: 19914282
• Product Code: NRY
• UDI-Device Identifier: 07613327459265
• UDI-Public: 07613327459265
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/09/2024
• Device Model Number: INC-11597-132
• Device Catalogue Number: INC-11597-132
• Device Lot Number: 17188-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 09/22/2022
• Supplement Report FDA Received Date: 11/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PUMP (UNKNOWN)
• Patient Sex: Unknown