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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a left middle cerebral artery (mca) stenosis case, subject guidewire could not be delivered in proximal of microcatheter.After removing it out, subject guidewire was found fractured.The fractured part was removed successfully, and the procedure was completed successfully with another device.No further information is available.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.The subject guidewire was not returned for analysis; therefore, physical as well as a functional testing could not be performed.The reported event is covered in the device direction 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 could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.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.While there are a number of potential causes for the reported issue, because the device was not returned and review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned.
Event or Problem Description
It was reported that during a left middle cerebral artery (mca) stenosis case, subject guidewire could not be delivered in proximal of microcatheter.After removing it out, subject guidewire was found fractured.The fractured part was removed successfully, and the procedure was completed successfully with another device.No further information is available.

• 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: 20031273
• Report Number: 3008853977-2024-00027
• Device Sequence Number: 6404811
• Product Code: DQX
• UDI-Device Identifier: 08714729441748
• UDI-Public: (01)08714729441748(17)250423(10)31485580
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K022357
• 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): 11/21/2024

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: 04/23/2025
• Device Catalogue Number: M003468150
• Device Lot Number: 31485580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/26/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2023
• 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: BALLOON (UNKNOWN); EXCELSIOR SL-10 MICROCATHETER (STRYKER); STENT (UNKNOWN)
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 62 KG
• Patient Race: Asian