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 Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure, the physician encountered resistance while advancing the subject catheter in tortuous anatomy.The distal part of subject catheter fractured.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
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 device was returned.There was no packaging returned with the device, therefore it cannot be confirmed that the correct device was returned.The damage noted to the device is consistent with the reported event.During the visual inspection, the distal 25cm of the catheter was broken /fractured.The catheter was noted to be deformed and extensively stretched.Functional testing was not performed due to the condition of 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.Additional information provided by the customer indicated that resistance was encountered while advancing the device around tortuosity.It is probable that the device was damaged due to friction experienced due to the tortuosity of the anatomy.An assignable cause of procedural factors will be assigned to the reported and analyzed events as this complaint appears to be associated with a product that met stryker and 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, the physician encountered resistance while advancing the subject catheter in tortuous anatomy.The distal part of subject catheter fractured.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• 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: 10176585
• Report Number: 3008853977-2020-00019
• Device Sequence Number: 2461619
• 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): 10/28/2020

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: 12/04/2022
• Device Model Number: INC-11597-132
• Device Catalogue Number: INC-11597-132
• Device Lot Number: 14678-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Initial Date Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 10/28/2020
• 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 PLUS LONG SHEATH (STRYKER); TRAK 21 MICROCATHETER (STRYKER); TREVO NXT RETRIEVER (STRYKER)