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

Catalog Number	INC-11814-146
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem 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stroke.Access setup was through the radial artery.After approximately 1-1.5 minutes of aspiration, the subject catheter was retracted and some resistance was felt.The subject catheter came back slowly with the resistance and eventually out of the non-stryker catheter.A contrast run was done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 or Problem 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stroke.Access setup was through the radial artery.After approximately 1-1.5 minutes of aspiration, the subject catheter was retracted and some resistance was felt.The subject catheter came back slowly with the resistance and eventually out of the non-stryker catheter.A contrast run was done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.
Additional 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'.
Additional Manufacturer Narrative
B2 outcomes attributed to ae - updated.B5 executive summary - updated.F10 / h6 health impact code grid - health effect - impact code - updated.
Event or Problem 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
• Common Device Name: 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
• Report Number: 3008853977-2023-00054
• Device Sequence Number: 14471183
• Product Code: NRY
• UDI-Device Identifier: 07613327519365
• UDI-Public: 07613327519365
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K172167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/18/2026
• Device Catalogue Number: INC-11814-146
• Device Lot Number: 22414-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 01/10/2024; 02/14/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 01/18/2024; 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 7F RIST CATHETER (NON-STRYKER); COLOSSUS GUIDEWIRE (NON-STRYKER); PENUMBRA ASPIRATION PUMP
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Male