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

Catalog Number	BRW084132-01
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Embolism/Embolus (4438); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure, the base catheter climbed past the horizontal petrous and the subject catheter and delivery assist catheter partially crossed and ingested the clot in the internal carotid artery (ica).The clot was extremely large and the vessel was dissected prior to the procedure.The clot created a few distal emboli which led to an m2 and two m4 occlusions.The m2 occlusion was resolved with a different catheter.No clinical consequences were reported to the patient due to this event.No additional information available.
Event or Problem Description
It was reported that during the procedure, the base catheter climbed past the horizontal petrous and the subject catheter and delivery assist catheter partially crossed and ingested the clot in the internal carotid artery (ica).The clot was extremely large and the vessel was dissected prior to the procedure.The clot created a few distal emboli which led to an m2 and two m4 occlusions.The m2 occlusion was resolved with a different catheter.No clinical consequences were reported to the patient due to this event.No additional information available.Update: further review of complaint details on 04 march 2025: by product assessment center management (pac), it is clarified that the subject stent distal emboli may be a part of the procedure and is not device related.Furthermore, the emboli in the m2 was resolved with aspiration, and the emboli in m4, in the physicians opinion, would resolve on its own.
Additional Manufacturer Narrative
Section b1 adverse event/product problem - corrected - no adverse event.Section h1 type of reportable event - corrected - no serious injury.B5 executive summary ¿ updated.D4 gtin ¿ corrected.H1 type of reportable event - corrected - no serious injury.F10 / h6 clinical signs, health impact, device code grid -updated.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• Brand Name: BROADWAY 8 .084IN ID X132CM-US
• Common Device Name: PERCUTANEOUS CATHETER
• 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: 21445663
• Report Number: 3012931345-2025-00042
• Device Sequence Number: 20663013
• Product Code: QJP
• UDI-Device Identifier: 07613327624106
• UDI-Public: (01)07613327624106(17)251205(10)0000759502
• Combination Product (Y/N): N
• 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): 03/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: BRW084132-01
• Device Lot Number: 0000759502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2025
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: ECHO CATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown