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	02/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that during procedure while the guide catheter (subject device) was advanced into the patient groin puncture site, the guide catheter broke.There were no clinical consequences to the patient.
Event or Problem Description
It was reported that during procedure while the guide catheter (subject device) was advanced into the patient groin puncture site, the guide catheter broke.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record confirms that the device met all material, assembly and performance specifications.Visual inspection was performed on the returned device and it was observed that the catheter was severely stretched and separated on the proximal side near the strain relief.The catheter inner coil was severely stretched and tangled.The shaft was also kinked approximately near the strain relief and slightly compressed along its length.Functional evaluation could not be performed due to the anomalies found on the catheter.The reported event was confirmed based on the product analysis.Additional information provided by the customer indicated that the break occurred at the groin puncture site while being advanced into the patient.Based on analysis and the information provided, a probable cause of procedural factors has been assigned to the investigation since 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/anatomical factors during use.

• 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: 8364658
• Report Number: 3008853977-2019-00020
• Device Sequence Number: 2034963
• Product Code: DQY
• UDI-Device Identifier: 07613327459203
• UDI-Public: 07613327459203
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/19/2019

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: No Information
• Device Expiration Date: 08/20/2021
• Device Catalogue Number: INC-11196-90
• Device Lot Number: 13262-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1