MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF AXS VECTA 071 INTERMEDIATE CATHETER (132CM); CATHETER, THROMBUS RETRIEVER

Catalog Number	INC-11129-132
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record review could not be performed since the lot number was not known.Visual inspection revealed that the catheter was returned with a wire inserted and could not be removed.The catheter proximal shaft was found to be broken/fractured and stretched on its distal shaft.The break occurred at approximately 107 cm from the strain relief and no other anomalies were observed.Functional evaluation could not be performed due to the anomalies found on the catheter.The reported issue is covered in the device directions for use.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 confirmed.It is probable that the device was damaged during the clinical procedure due to some procedural/anatomical factors encountered causing the as reported event, therefore assignable cause of procedural factors will be assigned to reported issue.
Event or Problem Description
Analysis of the returned device noted that the catheter shaft was broken.No consequences to the patient were reported.

• Brand Name: AXS VECTA 071 INTERMEDIATE CATHETER (132CM)
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• MDR Report Key: 9325107
• Report Number: 3008853977-2019-00067
• Device Sequence Number: 16705308
• Product Code: NRY
• UDI-Device Identifier: 07613327459234
• UDI-Public: 07613327459234
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2019

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 Catalogue Number: INC-11129-132
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1