MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS INFINITY LS - 90CM; CATHETER, PERCUTANEOUS

Catalog Number	GEN-10800-90
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the catheter broke.Procedure was completed using another device.No clinical consequences were reported to the patient.
Event or Problem Description
It was reported that during the procedure, the catheter broke.Procedure was completed using another device.No clinical consequences were reported to the patient.
Additional Manufacturer Narrative
Device evaluated by mfg and summary attached: updated.A device history record (dhr) review could not be performed because the lot number is unknown.Analysis of the device was noted to have blood both inside and outside of the catheter lumen.The catheter shaft was broken at approximately 25cm from the hub.Functional testing could not be performed due to the condition of the returned device.As per the information provided no anomalies were noted to the device prior to use.The nature of the break indicates that excessive force during removal of the device may have been a factor though this cannot be conclusively determined.This complaint appears to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.Therefore, an assignable cause of procedural factors will be assigned to the as reported catheter break.

• Brand Name: AXS INFINITY LS - 90CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8242420
• Report Number: 3008881809-2019-00022
• Device Sequence Number: 11332551
• Product Code: DQY
• UDI-Device Identifier: 07613327298260
• UDI-Public: 07613327298260
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 02/26/2019

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: GEN-10800-90
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 02/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1