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

Model Number	INC-11597-132
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Analysis of the returned device found that the subject catheter shaft broken/fractured during use.There were no clinical consequences to the patient reported as a result of this event.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the catheter was found to be broken and stretched.There was dried blood on the catheter.The catheter tip was found to be damaged.Functional testing was unable to be performed due to the catheter damage.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 catheter was seen to be broken, flattened, kinked bent stretched.Therefore the as reported can be confirmed.Additional information provided by the customer indicated that physician felt a good amount of resistance and said something did not feel right and the physician pulled out the vecta and it was unraveled.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
• 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: 13795944
• Report Number: 3008853977-2022-00014
• Device Sequence Number: 4029344
• Product Code: NRY
• UDI-Device Identifier: 07613327459265
• UDI-Public: 07613327459265
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 03/16/2022

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: 04/04/2024
• Device Model Number: INC-11597-132
• Device Catalogue Number: INC-11597-132
• Device Lot Number: 16936-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2021
• 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: AXS INFINITY LS PLUS LONG SHEATH (STRYKER); AXS OFFSET DELIVERY ASSIST CATHETER (STRYKER)
• Patient Age: 68 YR
• Patient Sex: Female