MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION THREADER; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	1865
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast and blood in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There was a pinhole at the marker band.There was no marker band damage detected.The inner shaft was buckled starting at the marker band and extending 2mm proximally.There was a guidewire stuck in the device.The guidewire lumen was flushed with water and the guidewire was removed.There was no obvious damage to the guidewire.The damage was consistent with an interaction from a guidewire.
Event or Problem Description
Reportable based on device analysis completed on 23nov2020 it was reported that the wire could not pass through and was caught in the balloon.The target lesion was located in the right coronary artery.A 1.2mmx12mm threader was selected for use.During procedure, it was noted that the distal tip of rotawire would not pass through when trying to remove the balloon.It appears that the wire was getting caught on the distal part of the balloon.Another rotawire was replaced and the procedure was completed.However, device analysis revealed a balloon pinhole.

• Brand Name: THREADER
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10949691
• Report Number: 2134265-2020-16890
• Device Sequence Number: 1220350
• Product Code: LOX
• UDI-Device Identifier: 08714729848134
• UDI-Public: 08714729848134
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K134031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/04/2020

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: 03/18/2022
• Device Model Number: 1865
• Device Catalogue Number: 1865
• Device Lot Number: 0025369485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1