MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF AXS VECTA 074 CATH 132CM - US; CATHETER, THROMBUS RETRIEVER

Catalog Number INC-11597-132

Device Problem Fracture (1260)

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

Event Date 08/10/2023

Event Type  malfunction  

Event Description

During direct aspiration of thrombus in the cavernous carotid artery (ais) the operator used the subject catheter to aspirate clot from the cavernous carotid artery.Once satisfied with the amount of time engaged in the clot, the physician began to pull the subject catheter out of the body and the subject catheter began to stretch and unraveled, while inside the patient¿s body.The procedure was completed successfully.No further information available.

Manufacturer Narrative

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

Event Description

During direct aspiration of thrombus in the cavernous carotid artery (ais) the operator used the subject catheter to aspirate clot from the cavernous carotid artery.Once satisfied with the amount of time engaged in the clot, the physician began to pull the subject catheter out of the body and the subject catheter began to stretch and unraveled, while inside the patient¿s body.The procedure was completed successfully.No further information available.

Manufacturer Narrative

Based on the results of the device history review (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 at 25.5cm from the shaft.The catheter shaft was seen to be stretched.There was an intermediate catheter and a guidewire stuck inside of the returned subject catheter device.The inner coil wind was seen to be exposed through the break and the shaft.The catheter tip was seen to be flat/crushed.The catheter shaft was seen to be kinked between 11 and 14cm from the tip.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 events ¿catheter shaft broken/fractured during use¿ and ¿catheter shaft stretched¿ were confirmed during analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The as reported events ¿catheter shaft broken/fractured during use¿ and ¿catheter shaft stretched¿ as well as the analysed events ¿catheter shaft kinked/bent¿, ¿catheter shaft broken/fractured during use¿, ¿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.

• Brand Name: AXS VECTA 074 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: 17712605
• MDR Text Key: 322983597
• Report Number: 3008853977-2023-00035
• Device Sequence Number: 1
• Product Code: NRY
• 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: 11/09/2023

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-11597-132
• Device Lot Number: 18693-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 09/08/2023
• Supplement Dates Manufacturer Received: 10/30/2023
• Supplement Dates FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2022
• 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
• Treatment: AXS OFFSET CATHETER (STRYKER)