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

Model Number	GEN-10800-90
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that after the catheter (subject device) was entered inside the patient's anatomy via femoral access point, the middle of the subject catheter shaft broke in half during the procedure.The broken shaft of the subject catheter was removed successfully from the patient's anatomy.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that after the catheter (subject device) was entered inside the patient's anatomy via femoral access point, the middle of the subject catheter shaft broke in half during the procedure.The broken shaft of the subject catheter was removed successfully from the patient's anatomy.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the catheter shaft was seen to be kinked bent at 43cm and 88cm.The reported complaint not was confirmed based on analysis.The catheter was not broken therefore the as reported will not be confirmed.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.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.The as analyzed catheter shaft kinked bent will be assigned procedural factors as 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 factors during use.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• Brand Name: AXS INFINITY LS 90CM - US
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11369559
• Report Number: 3008881809-2021-00095
• Device Sequence Number: 17090445
• Product Code: DQY
• UDI-Device Identifier: 07613327298260
• UDI-Public: 07613327298260
• Combination Product (Y/N): N
• 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): 07/01/2021

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: 01/07/2023
• Device Model Number: GEN-10800-90
• Device Catalogue Number: GEN-10800-90
• Device Lot Number: 22063571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Initial Date Received by Manufacturer: 02/01/2021
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1