MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY BROADWAY 8 .084IN ID X132CM-US; CATHETER, PERCUTANEOUS, NEUROVASCULATURE

Catalog Number	BRW084132-01
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter (subject device) was used in the medical procedure.However, the physician noted that the clot could not be pulled, on inspection the proximal of the subject catheter was noted to be kinked.The physician believed that air was being pulled out through an opening in the kink.Thus, the subject device was replaced and the procedure was completed.No clinical consequences were reported to the patient.

• Brand Name: BROADWAY 8 .084IN ID X132CM-US
• Common Device Name: CATHETER, PERCUTANEOUS, NEUROVASCULATURE
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer (Section G): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 24553657
• Report Number: 3012931345-2026-00045
• Device Sequence Number: 21215379
• Product Code: QJP
• UDI-Device Identifier: 07613327624106
• UDI-Public: (01)07613327624106(17)271012(10)0001077730
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K241768
• 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): 05/15/2026

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 Catalogue Number: BRW084132-01
• Device Lot Number: 0001077730
• 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: 02/17/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2025
• 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: IMPERATIVE CARE DUO PORT PUMP (NON-STRYKER).; ZOOM 55 CATHETERS (NON-STRYKER).
• Patient Sex: Unknown