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

Catalog Number INC-11988-132

Device Problem Fracture (1260)

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

Event Date 02/05/2024

Event Type  malfunction  

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.During visual/microscopic inspection, the catheter was returned partially stuck inside of a non-stryker catheter.The catheter shaft was seen to be broken/fractured 113 cm from the hub.The catheter shaft was seen to be flat/crushed 3 to 8cm from the catheter tip.The catheter tip was intact.Functional inspection could not be carried out due to the damage noted to 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.The reported catheter shaft flat/crushed was confirmed during analysis.The reported catheter shaft friction could not be replicated during device analysis; however, the analysis results are consistent with the reported event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The device was returned for analysis.The catheter was returned partially stuck inside of a non-stryker catheter.The catheter shaft was seen to be broken/fractured.The catheter shaft was seen to be flat/crushed.The catheter tip was intact.The as reported events of catheter shaft friction and catheter shaft flat/crushed as well as the as analyzed events of catheter shaft flat/crushed, catheter jammed, catheter shaft broken/fractured during use will be assigned procedural factors as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.

Event Description

The subject catheter was returned for analysis and the device investigation revealed that subject catheter shaft was broken during use.No clinical consequences were reported to the patient due to this event.

• Brand Name: AXS VECTA 071 CATH 132CM - CE
• 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: 19135072
• MDR Text Key: 341309269
• Report Number: 3008853977-2024-00015
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: INC-11988-132
• Device Lot Number: 17482-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2021
• 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