MAUDE Adverse Event Report: BOSTON SCIENTIFIC COSTA RICA TRANSEND 14 FLOPPY 300CM; WIRE, GUIDE, CATHETER

Catalog Number	M003468150
Medical Device Problem Codes	Positioning Failure (1158); Fracture (1260); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a stenosis procedure, the physician used the subject guidewire to advance the balloon into position.The physician found that the balloon could not continue to move forward when it reached a point 30 cm from the subject guidewire tip, and repeated attempts yielded the same result.Therefore, the balloon and the subject guidewire were withdrawn.And upon inspection, it was discovered that the subject guidewire coating had worn off and got detached at a point of 30 cm from the subject guidewire tip.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during a stenosis procedure, the physician used the subject guidewire to advance the balloon into position.The physician found that the balloon could not continue to move forward when it reached a point 30 cm from the subject guidewire tip, and repeated attempts yielded the same result.Therefore, the balloon and the subject guidewire were withdrawn.And upon inspection, it was discovered that the subject guidewire coating had worn off and got detached at a point of 30 cm from the subject guidewire tip.The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
D4 expiration date ¿ added.D4 gtin ¿ added.H4 manufacturing date ¿ added.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 (device history record) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.During visual inspection, there was evidence of damage to the subject guidewire ptfe (polytetrafluoroethylene) coating at 42.5cm from the distal end.There was bending noted to the distal 9cm section of the guidewire.The distal tip of the guidewire was intact as per photo 5.There was no fracture noted to the guidewire.The distal end of the ptfe coating was compared to a demonstration transend guidewire.The functional inspection was performed, and the guidewire was advanced through a demonstration microcatheter without difficulty.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 physician used a transend wire to advance the gateway balloon into position.The physician found that the balloon could not continue to advance when it reached 30 cm from the wire tip and repeated attempts yielded the same result.The balloon and wire were withdrawn and inspected.Upon inspection of the wire, it was discovered that the coating on the wire had peeled off and detached at a point 30 cm from the tip.Additional information provided by the customer indicated that the device was prepared for use as per the directions for use.There was no damage noted to the packaging prior to opening the packaging.The device was confirmed to be in good condition during preparation/prior to use on the patient.The continuous flush was set up and maintained throughout the clinical procedure.The device was returned for analysis, and it was noted that there was evidence of damage to the guidewire ptfe coating at 42.5 cm from the distal end.There was bending observed to the distal end of the guidewire at 9 cm.The distal tip of the guidewire was intact and there was no fracture noted to the guidewire.The distal end of the ptfe coating was compared to a demonstration transend guidewire.The guidewire passed the dimensional inspection with no fractures noted.The guidewire was advanced through a demonstration sl-10 microcatheter without difficulty.The reported guidewire ptfe coating peeling was confirmed, the reported guidewire broken/fractured during use was not confirmed and the reported catheter has difficulty tracking over guidewire was not replicated, however the analysis results are consistent with the reported event.Based on a review of all available information and the analysis of the returned device it is probable that due to procedural factors the balloon catheter was unable to be advanced into the guidewire which led to friction and damage of the ptfe coating as well as bending of the guidewire distal tip.The as reported event of ¿guidewire broken/fractured during use¿ will be assigned a probable cause of not confirmed.The as reported event of the ¿catheter has difficulty tracking over guidewire¿ will be assigned a probable cause of procedural factors.The as reported and analyzed damage of ¿guidewire ptfe coating peeling¿ and the as analyzed damage of the ¿guidewire distal end/tip kinked/bent¿ 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.

• 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 ; 5104132500
• MDR Report Key: 23064616
• Report Number: 3008853977-2025-00023
• Device Sequence Number: 15963535
• Product Code: DQX
• UDI-Device Identifier: 08714729441748
• UDI-Public: (01)08714729441748(17)251105(10)32796496
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/18/2025

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 Expiration Date: 11/05/2025
• Device Catalogue Number: M003468150
• Device Lot Number: 32796496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/24/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2023
• 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: GATEWAY BALLOON (STRYKER).
• Patient Sex: Unknown
• Patient Race: Asian