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

Model Number	M001468050
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that during procedure, the guidewire (subject device) broke.No additional information is available at this time.
Additional Manufacturer Narrative
The device history record review for the transend ex 014 lot # 22703212 confirmed that the device met all material, assembly and performance specifications.The subject device 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 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.While there are a number of potential causes for the reported issue, because review of available information failed to identify a definitive cause and because the device was not returned for analysis, a cause of undeterminable was assigned to this investigation.
Event or Problem Description
It was reported that during procedure, the guidewire (subject device) broke.
Additional Manufacturer Narrative
H10 section.D10: product available to stryker: updated.H3: device evaluated by mfg: updated.H3: summary attached: updated.Due to the automated mes system (manufacturing execution system), there are controls in the manufacturing process to ensure the product met specifications upon release.The reported event is covered in the device 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 device was returned and it was confirmed that the guidewire was broken and kinked.It is probable that the device was damaged during the clinical procedure causing the reported event.An assignable cause of procedural factors will be assigned to the reported and analyzed issues.
Event or Problem Description
It was reported that during procedure, the guidewire (subject device) broke.A new device was used.There were no clinical consequences 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 ; CR 20101
• MDR Report Key: 8587598
• Report Number: 3008853977-2019-00038
• Device Sequence Number: 11214970
• Product Code: DQX
• UDI-Device Identifier: 08714729187332
• UDI-Public: 08714729187332
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/24/2020

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: 09/24/2020
• Device Model Number: M001468050
• Device Catalogue Number: M001468050
• Device Lot Number: 22703212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Initial Date Received by Manufacturer: 05/02/2019
• Supplement Date Received by Manufacturer: 06/21/2019; 02/18/2020
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 06/21/2019; 02/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1