MAUDE Adverse Event Report: BOSTON SCIENTIFIC COSTA RICA TRANSEND EX 14 182CM; WIRE, GUIDE, CATHETER

Model Number	M001468050
Medical Device Problem Code	Unclear Information (4052)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned with no packaging, so the lot number could not be confirmed.During visual inspection the guidewire was broken/fractured at 71cm from the proximal end.A functional test could not be performed due to the condition of the device.Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.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.The reported complaint was confirmed based on analysis.Based on the event description, "catheterization microguide rupture", it is likely that the reported issue was for a guidewire fracture.The guidewire was broken/fractured at 71cm from the proximal end.This complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural and/or anatomical factors during use.Therefore, an assignable cause of procedural factors will be assigned to the event.
Event or Problem Description
The subject guidewire (subject device) was returned for analysis on (b)(6) 2020 and the guidewire was examined.Based on the investigation of the device, it was revealed that the guidewire was broken/fractured at 71cm from the proximal end.No clinical consequences were reported to the patient due to this event.

• Brand Name: TRANSEND EX 14 182CM
• 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: 10525088
• Report Number: 3008853977-2020-00029
• Device Sequence Number: 14216789
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2020

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: 07/09/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1