MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS CATALYST 7 .068IN ID X 132CM - US; CATHETER, THROMBUS RETRIEVER

Model Number	IC068132
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, after aspiration, when the physician removed the subject catheter from the patient's anatomy, the proximal part of the subject catheter was found broken.The physician removed the fractured fragment of the subject catheter out of the patient's anatomy.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H3 device evaluated by mfg: updated.H3 summary attached: updated.H4 manufacturing date: added.D4 expiration date: added.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 broken 6cm and 31cm from the catheter hub.The catheter shaft was seen to be kinked at 58cm and 60cm from the hub.There was dried blood seen along the distal shaft.Functional inspection was not required as the defect was confirmed.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 catheter was seen to be broken therefore confirming the as reported event.The catheter was also seen to be kinked bent.The as reported 'catheter shaft broken/fractured during use', as well as the as analyzed 'catheter shaft broken/fractured during use', '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.
Event or Problem Description
It was reported that during the procedure, after aspiration, when the physician removed the subject catheter from the patient's anatomy, the proximal part of the subject catheter was found broken.The physician removed the fractured fragment of the subject catheter out of the patient's anatomy.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: AXS CATALYST 7 .068IN ID X 132CM - US
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 13684510
• Report Number: 3008881809-2022-00108
• Device Sequence Number: 11239296
• Product Code: NRY
• UDI-Device Identifier: 07613327417227
• UDI-Public: 07613327417227
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K183464
• 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): 06/08/2022

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: 10/12/2023
• Device Model Number: IC068132
• Device Catalogue Number: IC068132
• Device Lot Number: 23195781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2022
• Supplement Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 03/07/2022
• Supplement Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FLOWGATE BALLOON GUIDE CATHETER (STRYKER); SYNCHRO 14 GUIDEWIRE (STRYKER)
• Patient Sex: Unknown