MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR 1018 STRAIGHT 1 TIP 150CM; CATHETER, PERCUTANEOUS

Model Number M0031441810

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2022

Event Type  malfunction  

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

It was reported that during an endovascular procedure in a patient, the radio opaque distal marker of the subject microcatheter was not visible under fluoroscopy.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

Section b1 adverse event/product problem - corrected - no product problem section h1 type of reportable event - corrected - no malfunction h4 manufacturing date ¿ added h3 device evaluated by mfg ¿updated h3 summary attached - updated d4 expiration date - added d9 product available to stryker ¿ updated d9 returned to manufacturer on ¿updated due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During visual/microscopic inspection, the catheter shaft was kinked 90 cm and 149.2cm from the catheter hub.The catheter tip was intact.The catheter hub was intact.During functional inspection: the catheters marker band was checked under fluoroscopy to check if the marker band was visible, the marker band was visible.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 defect was not confirmed based on analysis of the device.The catheter device met specifications when received for complaint investigation.The catheter marker band was checked under fluoroscopy and the marker band was visible.The as reported 'device or device component not visible under fluoroscopy' will be assigned not confirmed.The as analyzed 'catheter shaft kinked/bent' will be assigned handling damage as the issue is due to handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.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 Description

It was reported that during an endovascular procedure in a patient, the radio opaque distal marker of the subject microcatheter was not visible under fluoroscopy.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: EXCELSIOR 1018 STRAIGHT 1 TIP 150CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 16031881
• MDR Text Key: 308368344
• Report Number: 3008881809-2022-00647
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 04546540688118
• UDI-Public: 04546540688118
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/04/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2024
• Device Model Number: M0031441810
• Device Catalogue Number: M0031441810
• Device Lot Number: 22768296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 02/20/2023
• Supplement Dates FDA Received: 03/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1