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

Model Number 1865

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2020

Event Type  malfunction  

Event 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.

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 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.

Manufacturer Narrative

Bsc aware date: july 3, 2020.

Event 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
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10267143
• MDR Text Key: 198620342
• Report Number: 2134265-2020-09197
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729848134
• UDI-Public: 08714729848134
• Combination Product (y/n): N
• PMA/PMN Number: K134031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1