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

Catalog Number	INC-11129-132
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the thrombectomy procedure the subject catheter was used to retrieve the clot.During retrieval while the physician was pulling the subject catheter back, the tip of the subject catheter wasn¿t moving as it got fractured and unraveled.Patient¿s anatomy had average tortuosity.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during the thrombectomy procedure the subject catheter was used to retrieve the clot.During retrieval while the physician was pulling the subject catheter back, the tip of the subject catheter wasn¿t moving as it got fractured and unraveled.Patient¿s anatomy had average tortuosity.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.D4 expiration date - added.Based on the results of the device history record (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 12cm from the catheter tip.The catheter shaft was seen to be stretched/damaged.The inner coil wind was seen to be exposed through the break in the shaft.The catheter shaft was seen to be kinked 28 and 36 cm from the tip.The catheter tip and hub were intact.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 device was returned for analysis and the catheter shaft was seen to be broken/fractured, the catheter shaft was seen to be stretched/damaged.The inner coil wind was exposed through the break in the shaft.The catheter shaft was seen to be kinked/bent.The catheter tip and hub were intact.Therefore the as reported can be confirmed.The 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¿ 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.

• Brand Name: AXS VECTA 071 CATH 132CM - 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: 17950810
• Report Number: 3008853977-2023-00041
• Device Sequence Number: 6799458
• Product Code: NRY
• UDI-Device Identifier: 07613327459234
• UDI-Public: 07613327459234
• 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): 01/22/2024

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: 01/30/2026
• Device Catalogue Number: INC-11129-132
• Device Lot Number: 20901-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2023
• Supplement Date Received by Manufacturer: 12/29/2023
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2023
• 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: BMX 96 SHEATH (PENUMBRA); TRAK21 MICROCATHETER (STRYKER); TREVO STENT RETRIEVER (STRYKER)
• Patient Sex: Unknown