MAUDE Adverse Event Report: BOSTON SCIENTIFIC COSTA RICA TRANSEND EX 14 SOFT 205CM; WIRE, GUIDE, CATHETER

Model Number	M001468060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidewire (subject device) it was broken during the procedure causing a surgical delay of ten minutes.The procedure was completed successfully.There were no clinical consequences to the patient due to this event.
Additional Manufacturer Narrative
The device was returned and the lot number was confirmed with the packaging returned with the device.During visual inspection, only a partial section of the guide wire was returned and it was noted to be kinked at approximately 38cm from the proximal end and was broken/fractured at approximately 54cm from the proximal end.A balloon catheter was returned with the remaining section of the guidewire inserted and could not be removed.Unable to perform a functional test 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.Additional information provided by the customer indicated that no anomalies were noted to the device during initial inspection and preparation, the device was prepared as per the dfu.The reported complaint was confirmed based on analysis.The guidewire was returned broken/fractured, and a section of the guidewire was inserted in the concurrent balloon catheter device which could not be retrieved.The condition of the returned accessible partial guidewire suggests that excessive torque and manipulation during the procedure resulted in the observed damage.The as reported and as analyzed event of the guidewire broken/fractured during use and the as analyzed defect of the guidewire kinked/bent will be assigned procedural factors as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
It was reported that the guidewire (subject device) it was broken during the procedure causing a surgical delay of ten minutes.The procedure was completed successfully.There were no clinical consequences to the patient due to this event.

• Brand Name: TRANSEND EX 14 SOFT 205CM
• 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
• MDR Report Key: 12081585
• Report Number: 3008853977-2021-00024
• Device Sequence Number: 3348702
• Product Code: DQX
• UDI-Device Identifier: 08714729201212
• UDI-Public: 08714729201212
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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
• Report Date (Section B): 10/06/2021

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: 12/16/2021
• Device Model Number: M001468060
• Device Catalogue Number: M001468060
• Device Lot Number: 24943482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2021
• Initial Date Received by Manufacturer: 06/05/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 10/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1