MAUDE Adverse Event Report: BOSTON SCIENTIFIC COSTA RICA TRANSEND 14 FLOPPY 300CM; Wire, Guide, Catheter

Catalog Number	M003468150
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during the right mca m1 segment stent retrieval procedure, the physician found in-situ stenosis at the mid-m1 segment.After using balloon for dilation, a non-stryker stent was implanted.When the guidewire was being removed, the tip did not follow with it.The tip was broken off and remained inside the vessel.Due to the patient being agitated, no attempt was made to remove the tip fragment.Upon observation, the fractured guidewire tip was stable in the vessel, and blood flow in the affected vessel was not compromised, so the procedure was concluded with no clinical consequences to the patient.

• Brand Name: TRANSEND 14 FLOPPY 300CM
• Common Device Name: Wire, Guide, Catheter
• Manufacturer (Section D): BOSTON SCIENTIFIC COSTA RICA; coyol facility, 2546 first st.; propark free zone; alajuela 20101 ; CS 20101
• Manufacturer (Section G): Boston Scientific Costa Rica; coyol facility, 2546 first st.; propark free zone; alajuela 20101 ; CS 20101
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; +1(510)413-2500
• MDR Report Key: 25651447
• Report Number: 3008853977-2026-00015
• Device Sequence Number: 12228681
• Product Code: DQX
• UDI-Device Identifier: 08714729441748
• UDI-Public: (01)08714729441748(17)271017(10)37616086
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K944677
• 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): 10/01/2026

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: M003468150
• Device Lot Number: 37616086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2026
• Supplement Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 06/29/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2025
• 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: GATEWAY BALLOON CATHETER (STRYKER); GATEWAY BALLOON CATHETER (STRYKER).; REBAR 18 MICROCATHETER (MEDTRONIC); REBAR 18 MICROCATHETER (MEDTRONIC).; SOLITAIRE AB STENT ( MICRO THERAPEUTICS INC); SOLITAIRE AB STENT (MICRO THERAPEUTICS INC)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Race: Asian