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

Model Number	INC-11129-132
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a stroke intervention case, the aspiration catheter(subject device) was attempted to reach a clot located in the mca (middle cerebral artery (m1) segment but was not able to the reach the clot.The device was removed from the patient's body and was found to be fractured approximately 12cm from the distal tip.The physician replaced it with a another brand catheter and the clot was removed,completing the procedure without any clinical consequences to the patient.
Additional Manufacturer Narrative
A dhr (device history record) review was performed for the lot number implicated in this complaint and no manufacturing issue was found related to the reported event.The device met all required specifications when released.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.Visual and microscopic inspection of the returned device revealed that the catheter was seen to be broken/fractured along the shaft and therefore the reported event was confirmed.This complaint appears to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.
Event or Problem Description
It was reported that during a stroke intervention case, the aspiration catheter(subject device) was attempted to reach a clot located in the mca (middle cerebral artery (m1) segment but was not able to the reach the clot.The device was removed from the patient's body and was found to be fractured approximately 12cm from the distal tip.The physician replaced it with a another brand catheter and the clot was removed,completing the procedure without any clinical consequences to the patient.

• Brand Name: AXS VECTA 071 CATH 132CM - US
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• MDR Report Key: 9654845
• Report Number: 3008853977-2020-00005
• Device Sequence Number: 19259708
• Product Code: NRY
• UDI-Device Identifier: 07613327459234
• UDI-Public: 07613327459234
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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): 04/20/2020

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: 10/31/2022
• Device Model Number: INC-11129-132
• Device Catalogue Number: INC-11129-132
• Device Lot Number: 14583-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 01/31/2020
• Supplement Report FDA Received Date: 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INFINITY LONG SHEATH(STRYKER)
• Patient Age: 72 YR