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

Model Number	1865
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment occurred.A 1.2mm x 12mm threader balloon catheter was advanced for dilation.However, the balloon catheter and the wire became stuck.The microcatheter and wire had to be removed together and re-wire the lesion.The procedure was completed with a different device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Bsc aware date: july 3, 2020.Device evaluated by mfr.: returned product consisted of a threader balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was blood in the guidewire lumen.The balloon was loosely folded.The shaft was buckled in numerous areas.There was a 1mm long buckle 5mm from the tip, a 3mm long buckle 13mm from the tip, a 1mm long buckle 34mm from the tip, a 1mm long buckle 41mm from the tip, a 1mm long buckle 43mm from tip, a 1mm long buckle 48mm from the tip, a 3mm long buckle 51mm from the tip, a 2mm long buckle 82mm from the tip, and a 9mm long buckle 91mm from the tip.The device was soaked in a water bath for an hour to loosen any blood and contrast in the device.The guidewire that was stuck in the device was removed.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the catheter was frozen on the wire.
Event or Problem Description
It was reported that catheter entrapment occurred.A 1.2mm x 12mm threader balloon catheter was advanced for dilation.However, the balloon catheter and the wire became stuck.The microcatheter and wire had to be removed together and re-wire the lesion.The procedure was completed with a different device.There were no patient complications nor injuries reported.
Additional Manufacturer Narrative
Bsc aware date: july 3, 2020.
Event or Problem Description
It was reported that catheter entrapment occurred.A 1.2mm x 12mm threader balloon catheter was advanced for dilation.However, the balloon catheter and the wire became stuck.The microcatheter and wire had to be removed together and re-wire the lesion.The procedure was completed with a different device.There were no patient complications nor injuries reported.

• 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: 10267143
• Report Number: 2134265-2020-09197
• Device Sequence Number: 971542
• Product Code: LOX
• UDI-Device Identifier: 08714729848134
• UDI-Public: 08714729848134
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup,Followup
• Report Date (Section B): 08/28/2020

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: 02/18/2022
• Device Model Number: 1865
• Device Catalogue Number: 1865
• Device Lot Number: 0025229502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 07/20/2020; 08/24/2020
• Initial Report FDA Received Date: 07/13/2020
• Supplement Report FDA Received Date: 07/28/2020; 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1