MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF AXS VECTA 071 CATH 115CM - US; CATHETER, THROMBUS RETRIEVER

Model Number	INC-11129-115
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when the procedure was completed and removal of the catheter (subject device) from the patient anatomy, subject catheter was frayed and has strings falling off.There were no clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Additional Manufacturer Narrative
D4 expiration date - added.D9 product available to stryker- updated.D9 returned to manufacturer on- updated.H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the catheter shaft was seen to be flat/crushed 15cm from the catheter tip.There was an unknown material stuck to the catheter and appeared to be stuck under the catheter winds, the material was removed from the catheter.Although flattened, the catheter was not broken when the material was removed.The catheter was flushed and a patency mandrel was advanced but once the mandrel hit the flat area of the catheter, resistance was met and it was difficult to advance further.While removing the mandrel from the catheter the catheter shaft was damaged due to the resistance.As this shaft damage was caused during analysis it will no be assigned an as reported defect.The reported event is covered in the device direction 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 product was returned.The reported catheter shaft broken/fractured during use was not confirmed during analysis, no breaks were found on the catheter shaft.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It is likely that the substance extracted from the catheter coils is likely to be the inner lining of the outer catheter.It is believed that flattening the subject catheter device caused an increase in its outer diameter, leading to resistance while advancing it.It is also believed that the inner lining of the outer catheter got entangled within the subject catheter devices' coils.The as analyzed events of catheter shaft flat/crushed and catheter shaft friction 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.An assignable cause of not confirmed will be assigned to the as reported event of catheter shaft broken/fractured during use as the issue included a returned product review (visual, physical, and/or performance testing) which showed no evidence of either the alleged issue(s) or any defect which could have contributed to the event.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported when the procedure was completed and removal of the catheter (subject device) from the patient anatomy, subject catheter was frayed and has strings falling off.There were no clinical consequences were reported to the patient due to this event.

• Brand Name: AXS VECTA 071 CATH 115CM - 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 - MHRA ORG ID:31806; 47900 bayside parkway; fremont CA 94538
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 16662928
• Report Number: 3008853977-2023-00007
• Device Sequence Number: 17623435
• Product Code: NRY
• UDI-Device Identifier: 07613327459210
• UDI-Public: 07613327459210
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 05/12/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/27/2025
• Device Model Number: INC-11129-115
• Device Catalogue Number: INC-11129-115
• Device Lot Number: 20045-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2022
• 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: SL-10 MICROCATHETER (STRYKER)
• Patient Sex: Unknown