MAUDE Adverse Event Report: BOSTON SCIENTIFIC COSTA RICA TRANSEND EX 14 SOFT 205CM; WIRE, GUIDE, CATHETER

Catalog Number	M001468060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the subject guidewire tip broke during the procedure and was removed with the snare device.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H3 device evaluated by mfg ¿updated d9 product available to stryker ¿ updated d9 returned to manufacturer on ¿updated based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.During visual inspection the distal 7cm section of the guidewire was noted to be fractured.The distal 7cm section was returned extending from the microcatheters distal end.The microcatheter was noted to be kinked at 42 cm from the proximal end.Functional testing was not performed as the guidewire was fractured.The distal 7cm section was removed without difficulty from the microcatheter distal end.The reported event is covered in the device directions 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 complaint was confirmed based on analysis of the returned device.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that the tip of the microwire became detached and had to be removed from the brain vessel.The broken piece was retrieved with the help of a snare.The device was returned for analysis, and it was noted that the distal section of the guidewire was noted to be fractured.The distal section was returned extending from the microcatheters distal end.The microcatheter was noted to be kinked at 42 cm from the proximal end.The functional test was unable to be performed as the guidewire was fractured.The distal 7 cm section was removed without difficulty from the microcatheter distal end without difficulty.The reported event was confirmed.Based on a review of all available information and the analysis of the returned device it is probable that procedural factors during the device usage caused the reported and assigned events.The reported and assigned event : guidewire distal tip broken/fractured during use will be assigned a probable cause of procedural factors as this complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.
Event or Problem Description
It was reported that the subject guidewire tip broke during the procedure and was removed with the snare device.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TRANSEND EX 14 SOFT 205CM
• 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 ; 5104132500
• MDR Report Key: 21175629
• Report Number: 3008853977-2025-00001
• Device Sequence Number: 4263130
• Product Code: DQX
• UDI-Device Identifier: 08714729201212
• UDI-Public: (01)08714729201212(17)250508(10)31583653
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K931584
• 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): 04/17/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/24/2025
• Device Catalogue Number: M001468060
• Device Lot Number: 31583653
• 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: 01/07/2025
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2023
• 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: SNARE DEVICE (UNKNOWN).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown