MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS CATALYST 7 - 068X132 (FDA); CATHETER, PERCUTANEOUS

Catalog Number	IC068132
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated mes system (manufacturing execution system), there are controls in the manufacturing process to ensure the product met specifications upon release.The reported event is covered in the device 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 device was returned.The catheter shaft was noted to be broken/ fractured at 3cm from the hub.A functional test was not required as the defect was visually confirmed.Therefore, it was confirmed that the device was fractured.It is probable that the device was fractured during advancement during the clinical procedure.An assignable cause of procedural factors will be assigned to the investigation as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
Based on review of the investigation of the returned catheter (subject device), it was revealed that the catheter shaft was broken/ fractured during use.There were no clinical consequences to the patient.

• Brand Name: AXS CATALYST 7 - 068X132 (FDA)
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 9593590
• Report Number: 3008881809-2020-00006
• Device Sequence Number: 667389
• Product Code: DQY
• UDI-Device Identifier: 07613327417227
• UDI-Public: 07613327417227
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K183463
• 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
• Report Date (Section B): 01/15/2020

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 Expiration Date: 08/11/2021
• Device Catalogue Number: IC068132
• Device Lot Number: 21667454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/02/2020
• Initial Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1