MAUDE Adverse Event Report: BOSTON SCIENTIFIC COSTA RICA TRANSEND EX 014; WIRE, GUIDE, CATHETER

Model Number	M001468050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
During the procedure, it was reported that resistance was felt when advancing the guidewire (subject device) from the introducer sheath to the microcatheter.Therefore the guidewire was retrieved and it was found that the distal section of the guidewire was detached.The procedure was completed successfully after changing to another guidewire.No clinical consequences reported to the patient.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.Information available indicated that the device was prepared as per the dfu.Based on the information currently available the exact cause for the reported event cannot be determined.
Event or Problem Description
During the procedure, it was reported that resistance was felt when advancing the guidewire (subject device) from the introducer sheath to the microcatheter.Therefore the guidewire was retrieved and it was found that the distal section of the guidewire was detached.The procedure was completed successfully after changing to another guidewire.No clinical consequences reported to the patient.

• Brand Name: TRANSEND EX 014
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC COSTA RICA; coyol facility, 2546 first st.; propark free zone; alajuela 20101
• MDR Report Key: 6730858
• Report Number: 3008853977-2017-00010
• Device Sequence Number: 16486869
• Product Code: DQX
• UDI-Device Identifier: 08714729187332
• UDI-Public: (01)08714729187332(17)180930(10)19777278
• Combination Product (Y/N): N
• PMA/510(K) Number: K934122
• 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): 09/20/2017

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: 09/28/2018
• Device Model Number: M001468050
• Device Catalogue Number: M001468050
• Device Lot Number: 19777278
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/23/2017
• Supplement Date Received by Manufacturer: 08/23/2017
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER (UNKNOWN MANUFACTURER)