MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PT?; wire, guide, catheter

Model Number	H7493893104J0
Medical Device Problem Codes	Nonstandard Device (1420); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred requiring additional intervention.The patient underwent fibular artery and tibiofibular trunk angioplasty.A 300 cm j-tip pt? guidewire was inserted into a non-lesion segment of the infrapatellar artery.During advancement, the tip of the guidewire detached.The separated segment was successfully retrieved by catheter aspiration, and the procedure was completed using a different device.No patient complications were reported.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve the device status, but it was unable to be obtained.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve the device status, but it was unable to be obtained.Investigation results: device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record (dhr) review: it was confirmed that this device met manufacturing specification prior to distribution and there no manufacturing deviations which could have contributed to the reported event.Investigation conclusion: this investigation has been assigned the conclusion code of adverse event related to procedure.It is likely that the issue could be related to an excessive force applied to the device during procedure, as well as operational factors such as handling/technique.
Event or Problem Description
It was reported that tip detachment occurred requiring additional intervention.The patient underwent fibular artery and tibiofibular trunk angioplasty.A 300 cm j-tip pt? guidewire was inserted into a non-lesion segment of the infrapatellar artery.During advancement, the tip of the guidewire detached.The separated segment was successfully retrieved by catheter aspiration, and the procedure was completed using a different device.No patient complications were reported.

• Brand Name: PT?
• Common Device Name: wire, guide, catheter
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 25084090
• Report Number: 2124215-2026-24225
• Device Sequence Number: 16060729
• Product Code: DQX
• UDI-Device Identifier: 08714729471240
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K030617
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: H7493893104J0
• Device Catalogue Number: H7493893104J0
• Device Lot Number: 0036827732
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/06/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2026
• Supplement Date Received by Manufacturer: 05/28/2026; 09/02/2026
• Initial Report FDA Received Date: 05/05/2026
• Supplement Report FDA Received Date: 06/10/2026; 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male