MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF AXS VECTA 046 CATH 146CM - US; CATHETER, THROMBUS RETRIEVER

Catalog Number INC-11814-146

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/13/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that when the physician was treating a patient for a left p2 stroke.Access setup was through the radial artery.After approximately 1-1.5 minutes of aspiration, the subject catheter was retracted and some resistance was felt.The subject catheter came back slowly with the resistance and eventually out of the non-stryker catheter.A contrast run was done to check if p2 vessel was open which it was at that point.It was then noticed that the subject catheter was stretched distally and the distal fluoro marker was still in the patient's vessel, but more distal.There was no attempt made to retrieve the distal marker as it was too far distal in the anatomy.Following the case, the non-stryker was inspected and a kink was noticed.No additional information available.

Event Description

It was reported that when the physician was treating a patient for a left p2 stroke.Access setup was through the radial artery.After approximately 1-1.5 minutes of aspiration, the subject catheter was retracted and some resistance was felt.The subject catheter came back slowly with the resistance and eventually out of the non-stryker catheter.A contrast run was done to check if p2 vessel was open which it was at that point.It was then noticed that the subject catheter was stretched distally and the distal fluoro marker was still in the patient's vessel, but more distal.There was no attempt made to retrieve the distal marker as it was too far distal in the anatomy.Following the case, the non-stryker was inspected and a kink was noticed.No additional information available.Update: additional information received on 10-jan-2024 stated that intervention was required.No additional information available.

Manufacturer Narrative

Based on the results of the dhr (device history record) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.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.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 and the device was not returned, an assignable cause of undeterminable will be assigned to 'catheter shaft difficulty removing/withdrawing', 'catheter shaft stretched', 'ro marker(s) detached/separated/not visible under fluoroscopy' and 'un-retrieved device fragments'.

Manufacturer Narrative

B2 outcomes attributed to ae - updated.B5 executive summary - updated.F10 / h6 health impact code grid - health effect - impact code - updated.

Event Description

It was reported that when the physician was treating a patient for a left p2 stroke.Access setup was through the radial artery.After approximately 1-1.5 minutes of aspiration, the subject catheter was retracted and some resistance was felt.The subject catheter came back slowly with the resistance and eventually out of the non-stryker catheter.A contrast run was done to check if p2 vessel was open which it was at that point.It was then noticed that the subject catheter was stretched distally and the distal fluoro marker was still in the patient's vessel, but more distal.There was no attempt made to retrieve the distal marker as it was too far distal in the anatomy.Following the case, the non-stryker was inspected and a kink was noticed.No additional information available.Update: additional information received on 10-jan-2024 stated that intervention was required.No additional information available.

• Brand Name: AXS VECTA 046 CATH 146CM - 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: 18387220
• MDR Text Key: 331285961
• Report Number: 3008853977-2023-00054
• 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,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: INC-11814-146
• Device Lot Number: 22414-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2023
• 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: 7F RIST CATHETER (NON-STRYKER); COLOSSUS GUIDEWIRE (NON-STRYKER); PENUMBRA ASPIRATION PUMP
• Patient Outcome(s): Other; Required Intervention
• Patient Sex: Male