MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF AXS VECTA 071 CATH 132CM - US; CATHETER, THROMBUS RETRIEVER

Catalog Number INC-11129-132

Device Problem Fracture (1260)

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

Event Date 01/20/2024

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 the subject catheter would not advance and got broken/fractured.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.No further information available.

Manufacturer Narrative

Based on the results of the device history record (dhr) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.Visual and functional inspections were not performed as the device was not returned.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 the device was not returned, the reported events: ¿catheter shaft broken/fractured during use¿ and ¿catheter shaft friction¿ could not 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.

Event Description

It was reported that during the procedure the subject catheter would not advance and got broken/fractured.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.No further information available.

• Brand Name: AXS VECTA 071 CATH 132CM - 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: 18707897
• MDR Text Key: 335410805
• Report Number: 3008853977-2024-00006
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 07613327459234
• UDI-Public: 07613327459234
• 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: 05/01/2024

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-11129-132
• Device Lot Number: 20229-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2024
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2022
• 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