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

Catalog Number INC-11988-125

Device Problem Fracture (1260)

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

Event Date 03/13/2023

Event Type  malfunction  

Event Description

It was reported that during a thrombectomy procedure, the subject catheter was guided to the thrombus but during withdrawal under aspiration a resistance was noted.When the subject catheter was removed from the patient's anatomy, a break in the subject catheter wall was identified.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

Manufacturer Narrative

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

Event Description

It was reported that during a thrombectomy procedure, the subject catheter was guided to the thrombus but during withdrawal under aspiration a resistance was noted.When the subject catheter was removed from the patient's anatomy, a break in the subject catheter wall was identified.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

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 inspection the catheter shaft was seen to be broken/fractured 27cm form the hub.The catheter shaft was seen to be kinked/bent 16cm from the catheter tip.The catheter tip was seen to be flat/crushed.Functional inspection was not required as the break was confirmed during analysis.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 failure ¿catheter shaft broken/fractured during use¿ was confirmed during analysis.The reported failure ¿catheter shaft difficulty removing/withdrawing¿ 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.Additional information provided by the customer indicated that the device was prepared as per dfu, the device was confirmed to be in good condition during preparation/prior to use on the patient.Continuous flush was set up and maintained through out the clinical procedure.The device was returned for analysis and the catheter shaft was seen to be broken/fractured, the catheter shaft was seen to kinked/bent and the catheter tip was seen to be flat/crushed.Therefore, the reported failure can be confirmed.The reported events ¿catheter shaft broken/fractured during use¿, ¿catheter shaft difficulty removing/withdrawing¿ as well as the analyzed events ¿catheter shaft broken/fractured during use¿, catheter shaft kinked/bent¿, ¿catheter tip flat/crushed¿ 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.

• Brand Name: AXS VECTA 071 CATH 125CM - 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: 16851772
• MDR Text Key: 314352370
• Report Number: 3008853977-2023-00015
• 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,Followup
• Report Date: 06/15/2023

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 Catalogue Number: INC-11988-125
• Device Lot Number: 18515-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2023
• Initial Date FDA Received: 05/02/2023
• Supplement Dates Manufacturer Received: 05/29/2023
• Supplement Dates FDA Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2021
• 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