MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF AXS INFINITY LS PLUS LONG SHEATH (90CM); CATHETER, PERCUTANEOUS

Catalog Number	INC-11196-90
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the proximal section of the guide catheter(subject device) broke during removal patient from the patient at the end of the procedure.The physician used a guidewire to remove all of the broken guide catheter from the patient.There were no reported clinical consequences to the patient.
Event or Problem Description
It was reported that the proximal section of the guide catheter(subject device) broke during removal patient from the patient at the end of the procedure.The physician used a guidewire to remove all of the the broken guide catheter from the patient.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Visual inspection revealed that the catheter was kinked and separated on several places along its proximal section distal to and from the strain relief.The inner coils were stretched from the strain relief as well.Functional testing could not be performed due to the damaged condition of the returned catheter.Information available indicated that the physician tested the rest of the catheter to see how easily it would kink/fracture.It is possible that the device kinked and subsequently fractured due to excessive manipulation during the procedure.Based on the information currently available, it is probable that some procedural factors encountered during the procedure limited the performance of the catheter contributing to the reported and observed damages.Therefore, an assignable cause of component failure has been assigned to this investigation.

• Brand Name: AXS INFINITY LS PLUS LONG SHEATH (90CM)
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• MDR Report Key: 8511759
• Report Number: 3008853977-2019-00032
• Device Sequence Number: 19245090
• Product Code: DQY
• UDI-Device Identifier: 07613327459203
• UDI-Public: 07613327459203
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K152876
• 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): 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/10/2021
• Device Catalogue Number: INC-11196-90
• Device Lot Number: 13436-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2019
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 06/10/2019
• 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: AXS VECTA CATHETER(STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention