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

Model Number	M001468080
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned, and the reported lot number was confirmed from the returned packaging.During visual inspection, the guidewire distal tip was noted to be kinked with some evidence of stretching.There was a piece of metal noted to be protruding from the guidewire at 1cm from the distal tip.On inspection it was noted that this was the guidewire core wire.A functional test was not performed as the defect was visually confirmed.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.The device failed to meet specifications when received for complaint investigation.As per the event description, "during navigation of sl10 microcatheter with guidewire, the tip of the guidewire was got stuck in the stent.It was difficult to remove from the stent, but it was finally removed without breakage.According to the physician, unknown metal piece was found on the removed guidewire tip".The device was returned, and the distal end of the guidewire core wire was noted to be broken and protruding from the distal end of the guidewire, the guidewire was also noted to be kinked and stretched.It is probable that the guidewire was damaged as a result of the difficulty experienced in removing it from the stent.An assignable cause of caused by other will be assigned to the reported events as the investigation indicates another product caused the issue event.
Event or Problem Description
The guidewire (subject device) was returned for analysis and it was discovered that it was broken/fractured inside the patient's anatomy.The procedure was completed successfully.There are no clinical consequences reported to the patient.

• Brand Name: TRANSEND EX 14 PLATINUM 205CM
• 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: 10077071
• Report Number: 3008853977-2020-00015
• Device Sequence Number: 2916218
• Product Code: DQX
• UDI-Device Identifier: 08714729326267
• UDI-Public: 08714729326267
• Combination Product (Y/N): N
• Initial Reporter Country: JP
• PMA/510(K) Number: K971254
• 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): 05/20/2020

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: 09/10/2020
• Device Model Number: M001468080
• Device Catalogue Number: M001468080
• Device Lot Number: 22776155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 05/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1