MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF AXS INFINITY LS PLUS LONG SHEATH (80CM); CATHETER, PERCUTANEOUS

Catalog Number	INC-11196-80
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during carotid stenting procedure at the end of the case, as the long sheath catheter (subject device) was being removed from the patient¿s body, the long sheath catheter shaft broke by the hub location.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 stretched and separated just distal to the hub under the strain relief.The catheter was kinked on the proximal side and the catheter the inner coil was stretched.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 down by the hub when the catheter was being removed from the body at the end of the case.Based on visual inspection, the catheter appeared to have stretched and separated due to excessive manipulation during use.As a result, a probable cause of handling damage has been assigned to the reported event and analyzed anomalies.
Event or Problem Description
It was reported that during carotid stenting procedure at the end of the case, as the long sheath catheter (subject device) was being removed from the patient¿s body, the long sheath catheter shaft broke by the hub location.There were no clinical consequences to the patient.

• Brand Name: AXS INFINITY LS PLUS LONG SHEATH (80CM)
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• MDR Report Key: 8446440
• Report Number: 3008853977-2019-00023
• Device Sequence Number: 1785208
• Product Code: DQY
• UDI-Device Identifier: 07613327459197
• UDI-Public: 07613327459197
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 05/21/2019

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: 08/13/2021
• Device Catalogue Number: INC-11196-80
• Device Lot Number: 13245-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 05/21/2019
• 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: GUIDE CATHETER (UNKNOWN MANUFACTURER)