MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF AXS VECTA 074 CATH 132CM - US; CATHETER, THROMBUS RETRIEVER

Model Number	INC-11597-132
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that during carotid occlusion case, the middle shaft section of the catheter (subject device) broke due to interaction with a guide catheter while the physician was withdrawing the subject catheter from the patient's anatomy.All the fractured parts of the subject catheter were successfully removed from the patient¿s anatomy.The physician used another catheter and completed the procedure successfully.There were no clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.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 reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Additional information provided by the customer indicated that the device was prepared as per the dfu, continuous flush was maintained, and there was severe tortuosity noted during the case which was described as challenging.According to the physician, he believed the guide catheter ovalized and broke the catheter as he was withdrawing it.Based on this information, this complaint appears to be associated with a product that met design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural and/or anatomical factors during use.Therefore, an assignable cause of procedural factors will be assigned to the reported complaint.
Event or Problem Description
It was reported that during carotid occlusion case, the middle shaft section of the catheter (subject device) broke due to interaction with a guide catheter while the physician was withdrawing the subject catheter from the patient's anatomy.All the fractured parts of the subject catheter were successfully removed from the patient¿s anatomy.The physician used another catheter and completed the procedure successfully.There were no clinical consequences were reported to the patient due to this event.

• Brand Name: AXS VECTA 074 CATH 132CM - US
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• MDR Report Key: 10022690
• Report Number: 3008853977-2020-00013
• Device Sequence Number: 11388459
• Product Code: NRY
• UDI-Device Identifier: 07613327459265
• UDI-Public: 07613327459265
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K172167
• 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): 06/02/2020

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: 11/12/2022
• Device Model Number: INC-11597-132
• Device Catalogue Number: INC-11597-132
• Device Lot Number: 14622-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/20/2020
• Supplement Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 05/04/2020
• Supplement Report FDA Received Date: 06/02/2020
• 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: AXS INFINITY GUIDE CATHETER (STRYKER)