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 Consequences Or Impact To Patient (2199)
Date of Event	03/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the guide catheter shaft (subject device) fractured inside the patient.The physician replaced it with a new guide catheter and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
Manufacturing date ¿ added.Device evaluated by mfg ¿updated.Summary attached - updated.Expiration date - added.The device history record confirms that the device met all material, assembly and performance specifications.Visual inspection was performed on the returned sample and it was observed the long sheath was found to be kinked and separated at distal to the strain relief.In addition, the catheter shaft appeared to have kinked first and then separated.Functional testing could not be performed based on the damaged condition of the returned device.The device was stated to be in good condition and was prepared according to the dfu specifications.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.It is likely that procedural factors contributed to the reported and observed damages limiting the performance of the guide catheter during the clinical procedure, therefore a cause of procedural factors has been assigned to the reported issue.
Event or Problem Description
It was reported that during the procedure, the guide catheter shaft (subject device) fractured inside the patient.The physician replaced it with a new guide catheter and continued the procedure without clinical consequences to the patient.

• 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: 8458525
• Report Number: 3008853977-2019-00025
• Device Sequence Number: 19597313
• Product Code: DQY
• UDI-Device Identifier: 07613327459203
• UDI-Public: 07613327459203
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/28/2019

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 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: 03/20/2019
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 05/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1