MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF AXS VECTA 071 INTERMEDIATE CATHETER (132CM); CATHETER, THROMBUS RETRIEVER

Catalog Number	INC-11129-132
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that friction was experienced while inserting the intermediate catheter(subject device) into the guide catheter and the subject intermediate catheter was broken from the proximal end after being inserted into the guide catheter.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
Expiration date - added.Device evaluated by mfg - updated.Summary attached - updated.Manufacturing date ¿ added.The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was returned without the packaging hoop.The visual inspection revealed that the subject catheter shaft was broken/fractured at the proximal end at approximately 9 cm from the strain relief, the catheter shaft was kinked throughout its length and the distal tip was noted kinked.In the functional testing, the device was flushed and there was no evidence of blood within.The device was stated to be in good condition and was prepared according to the dfu specifications.The reported issue is covered in the device directions for use.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 was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information indicated that no anomalies were noted with the device prior to use.It is likely that the subject catheter shaft was damaged during the removal from the hoop and was not noted during the removal process.It is most likely the catheter shaft fractured completely during the procedure due to manipulation of the device.Therefore, a cause of handling damage has been assigned to this investigation.
Event or Problem Description
It was reported that friction was experienced while inserting the intermediate catheter(subject device) into the guide catheter and the subject intermediate catheter was broken from the proximal end after being inserted into the guide catheter.There were no reported clinical consequences to the patient.

• Brand Name: AXS VECTA 071 INTERMEDIATE CATHETER (132CM)
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• MDR Report Key: 9192415
• Report Number: 3008853977-2019-00065
• Device Sequence Number: 1879260
• Product Code: NRY
• UDI-Device Identifier: 07613327459234
• UDI-Public: 07613327459234
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/10/2019

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: 10/30/2021
• Device Catalogue Number: INC-11129-132
• Device Lot Number: 13520-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 12/10/2019
• 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 LONG SHEATH GUIDECATHETER(STRYKER).