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

Model Number	INC-11196-90
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that during procedure, the subject catheter was used to access the femoral site and the hub was separated from the subject catheter.The subject catheter was removed and replaced with another guide catheter.It was suspected that the subject catheter was used in a long stroke case which could cause of the break.The procedure completed without clinical consequences to the patient.
Additional Manufacturer Narrative
Although the dhr could not be reviewed because the lot number remains unknown, there are controls in the manufacturing process to ensure the product met specifications upon release.Visual/microscopic inspection found the device was returned attached to an rhv.The device was fractured at the hub under the strain relief.The inner shaft coil wire braid was exposed and stretched.There was a minor kink/bend on the catheter shaft from the strain relief.The reported event is covered in the device directions for use (dfu).As well, 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.Additional information provided by the customer indicated that the device was confirmed to be in good condition prior to use and was prepared as per the dfu, continuous flush was maintained, and the fracture occurred during a long stroke case where several different aspiration catheters went in and out of the infinity plus.Device analysis revealed the catheter shaft was slightly bent at the proximal shaft and was fractured at the hub under the strain relief.Based on inspection, the fracture likely occurred due to handling damage from extended use of the device, which aligns with the event description which states that it was a long case where the physician went in and out multiple times with different aspiration catheters.Therefore, an assignable cause of handling damage will be assigned to the reported event and device analysis 'catheter shaft broken/fractured during use' and 'catheter shaft kinked/bent'.
Event or Problem Description
It was reported that during procedure, the subject catheter was used to access the femoral site and the hub was separated from the subject catheter.The subject catheter was removed and replaced with another guide catheter.It was suspected that the subject catheter was used in a long stroke case which could cause of the break.The procedure completed without clinical consequences to the patient.

• Brand Name: AXS INFINITY LS PLUS 90CM - US
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork CA NA ; EI NA
• MDR Report Key: 10274119
• Report Number: 3008853977-2020-00023
• Device Sequence Number: 2603374
• Product Code: DQY
• UDI-Device Identifier: 07613327459203
• UDI-Public: 07613327459203
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2020

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 Model Number: INC-11196-90
• Device Catalogue Number: INC-11196-90
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 11/03/2020
• 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: ASPIRATION CATHETER (UNKNOWN MANUFACTURER); BALT SHEATH