MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF AXS VECTA 046 CATH 160CM - US; CATHETER, THROMBUS RETRIEVER

Model Number INC-11814-160

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text: the device is not available to the manufacturer.

Event Description

It was reported that during an endovascular surgery for m2 stroke, when the subject catheter was tried to pull back, there was resistance and the proximal end of the subject catheter was coming back but the distal marker was not moving on fluoro.The physician was able to pull the entire system out without anything left behind in the patient but the subject catheter had stretched distally.There was a surgical delay of 5 minutes due to this event.The procedure was completed successfully by replacing the subject device.No other clinical consequences were reported to the patient due to this event.

Event Description

It was reported that during an endovascular surgery for m2 stroke, when the subject catheter was tried to pull back, there was resistance and the proximal end of the subject catheter was coming back but the distal marker was not moving on fluoro.The physician was able to pull the entire system out without anything left behind in the patient but the subject catheter had stretched distally.There was a surgical delay of 5 minutes due to this event.The procedure was completed successfully by replacing the subject device.No other clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

Although the dhr could not be reviewed because the lot number remains unknown, there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual testing as well as functional testing cannot be performed.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.The device was not returned and therefore the as reported cannot be confirmed.The as reported 'catheter tip damaged', 'catheter shaft difficulty removing/withdrawing' and 'catheter tip broken/fractured during use' will be assigned undeterminable as while there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned.

• Brand Name: AXS VECTA 046 CATH 160CM - US
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• Manufacturer (Section G): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 17321963
• MDR Text Key: 319110973
• Report Number: 3008853977-2023-00030
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/21/2023

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
• Device Operator: Health Professional
• Device Model Number: INC-11814-160
• Device Catalogue Number: INC-11814-160
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 09/19/2023
• Supplement Dates FDA Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SYNCHRO GUIDEWIRE (STRYKER)