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

Catalog Number	M003468150
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the physician found the tip of the subject guidewire had coating peeling.Additional information received confirmed there was hydro peeling to the subject guidewire.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 the physician found the tip of the subject guidewire had coating peeling.Additional information received confirmed there was hydro peeling to the subject guidewire.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
B1 product problem - corrected - no product problem.D4- gtin- updated.H1 type of reportable event - corrected - no malfunction.H3-device evaluated by mfg-updated.H6 type of investigation - method code grid - updated.H6 investigation findings - results code grid - updated.H6 investigation conclusions - conclusion code grid - updated.Based on the results of the device history record (dhr) review, there is no indication that the device, labelling or packaging failed to meet its specifications when released.During visual inspection there were no anomalies noted to the guidewire.The distal tip was confirmed to be intact.During functional inspection the guidewire as hydrated and no anomalies were noted.The reported event ¿hydrophilic coating peeling¿ was not confirmed.It is probable that the distal 3cm coil was thought to be peeled as this has a different appearance to other transend guidewires.The reported event is covered in the device directions for use (dfu).Also, 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.It was reported that the physician found tip of the guidewire had coating peeled.Additional information provided by the customer indicated that there was no damage noted to the packaging prior to opening the packaging.The device was returned for analysis, and it was noted that there were no anomalies noted to the guidewire.The distal tip was confirmed to be intact.The guidewire passed the od and the guidewire was hydrated, no anomalies were noted.The reported hydrophilic coating peeling was not confirmed.It is probable that the distal 3cm coil was thought to be peeled as this has a different appearance to other transend guidewires.Based on a review of all available information, the reported event ¿hydrophilic coating peeling¿ will be assigned a probable cause of not confirmed and the analyzed event : ¿device within specification¿ will be assigned a probable cause of undeterminable since although there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned.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: 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: 25323137
• Report Number: 3008853977-2026-00012
• Device Sequence Number: 12082349
• Product Code: DQX
• UDI-Device Identifier: 08714729441748
• 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): 09/16/2026

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 Catalogue Number: M003468150
• Device Lot Number: 36795476
• Date Returned to Manufacturer: 05/27/2026
• 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: 05/06/2026
• Supplement Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2025
• 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: TARGET COIL (STRYKER).
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Race: Asian