MAUDE Adverse Event Report: BOSTON SCIENTIFIC COSTA RICA TRANSEND EX 014/205 SOFT TIP; WIRE, GUIDE, CATHETER

Catalog Number	M001468060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/12/2018
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 the guidewire was noted to be fractured in the middle suddenly inside the patient without any tough movement.The procedure was completed with another of the same device and the patient was stable following the procedure.No further information is available for now.
Additional Manufacturer Narrative
Device evaluated by mfg: updated.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.During the analysis of the returned device, it was revealed that the guidewire was fractured inside the patient and kinked just distal to the fractured site.In addition, magnified examination of the fracture site showed the hypotube and inner core wire were fractured.The functioning test could not be performed due to the damaged condition of the returned device.Additional information provided by the customer indicated that the guidewire was properly flushed prior to being introduced inside the patient and the wire separated in the middle during the procedure without any tough movement.From the condition of the device, it appears the guidewire was bent first and then fractured.Although it was stated that the wire separated without any tough movement, the damage found on the returned device indicated that excessive manipulation of the device occurred during use.Based on the information currently available, an assignable cause of handling damage will be assigned to this event.
Event or Problem Description
During the procedure, it was reported that the guidewire was noted to be fractured in the middle suddenly inside the patient without any tough movement.The procedure was completed with another of the same device and the patient was stable following the procedure.No further information is available for now.
Additional Manufacturer Narrative
Product available to stryker: updated; expiration date: added; returned to manufacturer on: updated; device evaluated by mfg: updated; manufacturing date: added.
Event or Problem Description
During the procedure, it was reported that the guidewire was noted to be fractured in the middle suddenly inside the patient without any tough movement.The procedure was completed with another of the same device and the patient was stable following the procedure.No further information is available for now.

• Brand Name: TRANSEND EX 014/205 SOFT TIP
• 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: 8171672
• Report Number: 3008853977-2018-00075
• Device Sequence Number: 1459534
• Product Code: DQX
• UDI-Device Identifier: 08714729201212
• UDI-Public: 08714729201212
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• 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,Followup
• Report Date (Section B): 02/25/2019

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: 05/21/2020
• Device Catalogue Number: M001468060
• Device Lot Number: 22152524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2019
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 01/07/2019; 02/08/2019
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 01/30/2019; 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1