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

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	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during left middle cerebral artery infarction procedure, the distal tip of the subject catheter was broken off.The subject catheter was removed from the patient anatomy.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
B1 adverse event - corrected - no product problem b5 - executive summary - updated h1 type of reportable event - corrected - no malfunction g4 pma/510(k - corrected d4 gtin - corrected d2a common device name - corrected d2b product code - corrected h4 manufacturing date ¿ added d4 expiration date - added h3 device evaluated by mfg ¿updated there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, it was observed that the subject catheter shaft was seen to be kinked/bent, and the subject catheter tip was found to be intact.The scout catheter tip was noted to be broken/fractured, and the subject catheter hub was intact.Functional inspection was not required.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 reported event catheter tip broken/fractured during use was not confirmed during analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that continuous flush set up and maintained throughout the procedure.No damage was noted to the packaging prior to opening, the subject device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu.The subject device was returned for analysis.The subject catheter shaft was seen to be kinked/bent.The subject catheter tip was found to be intact.The subject scout catheter tip was noted to be broken/fractured.The subject catheter hub was intact.An assignable cause of procedural factors will be assigned to the as analyzed codes catheter shaft kinked/bent and accessory damaged as these defects are 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 and/or anatomical factors during use.An assignable cause of not confirmed was assigned to the as reported code catheter tip 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 that during left middle cerebral artery infarction procedure, the distal tip of the subject catheter was broken off.The subject catheter was removed from the patient anatomy.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.The subject catheter was returned for analysis.The catheter was examined, and it was discovered that the reported event of the subject catheter tip being broken/fractured during use was not confirmed.The subject catheter tip and hub was found to be intact; the shaft of subject catheter was found kinked/bent.The subject scout catheter tip was noted to be broken/fractured.

• Brand Name: AXS VECTA 071 CATH 132CM - US
• Common Device Name: CATHETER, PERCUTANEOUS, NEUROVASCULATURE
• 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: 19810366
• Report Number: 3008853977-2024-00022
• Device Sequence Number: 8389864
• Product Code: QJP
• UDI-Device Identifier: 07613327459234
• UDI-Public: (01)07613327459234(17)250618(10)19679-01
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200206
• 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): 10/11/2024

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: 06/18/2025
• Device Catalogue Number: INC-11129-132
• Device Lot Number: 19679-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2022
• 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
• Patient Sex: Unknown