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

Catalog Number	M001468060
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record could not be performed because the lot number was not reported.The subject guidewire was returned with the torque device on the guidewire and along with the transform balloon catheter.The visual inspection revealed that guidewire was jammed in the transform catheter.The guidewire approximately 1.5cm distal section was protruding through the transform catheter distal end.The guidewire was shaped on its distal section.The transform balloon catheter was twisted on its distal section between distal tip and distal tip marker.The transform catheter was inflated, and efforts were made to pull the guidewire out of the transform catheter.The guidewire was jammed, the guidewire could not be pulled out of the transform catheter.The guidewire was examined.The guidewire was slightly bent along its proximal length.The guidewire ptfe coating was examined under magnification.The ptfe coating was scrapped off at approximately 32.0cm from its proximal section.During functional testing, the guidewire was jammed in the transform catheter.The transform catheter balloon was inflated and deflated without any problems.There was small amount of blood in the balloon.The guidewire was jammed in the catheter and could not be advanced or pulled.Per the investigation for the transform catheter, the use of contrast can cause binding of the guidewire within the distal tip of the balloon catheter if adequate hydration is not maintained, however this cannot be definitively determined.It is probable that the guide wire was damaged and was jammed within the distal tip of the balloon catheter and subsequently causing damage to the balloon catheter distal tip during the attempt to remove the guide wire.An assignable cause of procedural factors will be assigned to the guidewire tip damage, kink and jamming issue.It is probable that the ptfe coating peeling was caused by overtightening of the returned torque device.Per the device dfu: " excessive tightening of the torque device onto the wire may result in abrasion of the coating of the wire." therefore, an assignable cause of use error will be assigned to the analyzed guidewire ptfe coating peeling.
Event or Problem Description
Based on the investigation of the returned product, it was found that the guidewire ptfe coating was scrapped off.There were no clinical consequences to the patient.

• 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: 7881997
• Report Number: 3008853977-2018-00049
• Device Sequence Number: 2488696
• Product Code: DQX
• UDI-Device Identifier: 08714729201212
• UDI-Public: 08714729201212
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 09/17/2018

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 Catalogue Number: M001468060
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 09/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1