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

Model Number INC-11129-132

Device Problem Fracture (1260)

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

Event Date 11/08/2022

Event Type  malfunction  

Manufacturer Narrative

Based on the results of the 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 and the inner coil wind was seen to have unwound from the inner catheter and was exposed through the break.The catheter tip was seen to be flat.The catheter shaft was seen to be flat.The catheter shaft was seen to be stretched.Functional inspection was not carried out due to the condition of the returned catheter.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 stretched¿ was confirmed during analysis.The reported ¿catheter shaft difficulty removing/withdrawing¿ could not be confirmed; 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 there was no damage noted to the packaging prior to preparation of the device, there were no anomalies noted to the device after removal from the packaging or prior to preparation, the device was prepared as per the dfu.Continuous flush was maintained for the duration of the procedure.Patient's anatomy was very tortuous, and lot of resistance was encountered during the retrieval.The device was returned for analysis and the catheter shaft was seen to be broken and the inner coil wind was seen to have unwound from the inner catheter and was exposed through the break, the catheter tip was seen to be flat, the catheter shaft was seen to be flat, and the catheter shaft was seen to be stretched.The as reported ¿catheter shaft stretched¿ and ¿catheter shaft difficulty removing/withdrawing¿ and as analyzed ¿catheter shaft broken/fractured during use¿, ¿catheter tip flat/crushed¿, ¿catheter shaft flat/crushed¿ and ¿catheter shaft stretched¿ 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

Analysis of the returned device found that the subject catheter shaft was broken/fractured during use.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully.

• 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: 16537047
• MDR Text Key: 311225791
• Report Number: 3008853977-2023-00004
• 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
• Report Date: 03/14/2023

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-11129-132
• Device Catalogue Number: INC-11129-132
• Device Lot Number: 18557-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2023
• Initial Date FDA Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2021
• 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