MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF AXS VECTA 071 CATH 125CM - US; CATHETER, THROMBUS RETRIEVER

Catalog Number INC-11129-125

Device Problem Fracture (1260)

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

Event Date 02/27/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during the procedure, physician used a guide catheter to guide the subject catheter to the target lesion.However, physician felt resistance while bringing the subject catheter to the proximal of the target lesion.Physician checked under fluoroscopy and found that the proximal tip of the subject catheter was broken.The subject catheter was removed and visually confirmed to be broken.The subject catheter was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

H4 manufacturing date - added.D4 expiration date - added.Based on the results of the dhr (device history record) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.The subject device is not available; therefore, functional testing as well as visual 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.As per the additional information, the patient's anatomy was severely tortuous.It is possible that severely tortuous anatomy of the patient contributed to failure device.As the device was not returned, the as reported cannot be confirmed.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 to as reported "catheter shaft broken/fractured during use" and "catheter shaft difficulty advancing".

Event Description

It was reported that during the procedure, physician used a guide catheter to guide the subject catheter to the target lesion.However, physician felt resistance while bringing the subject catheter to the proximal of the target lesion.Physician checked under fluoroscopy and found that the proximal tip of the subject catheter was broken.The subject catheter was removed and visually confirmed to be broken.The subject catheter was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: AXS VECTA 071 CATH 125CM - 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: 18944850
• MDR Text Key: 338885935
• Report Number: 3008853977-2024-00010
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 05/30/2024

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 Catalogue Number: INC-11129-125
• Device Lot Number: 22037-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2024
• Initial Date FDA Received: 03/20/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2023
• 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: AXS OFFSET GUIDE CATHETER (STRYKER)