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

Model Number	1865
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 99% stenosed, 12mmx4mm, focal target lesion was located in the moderately tortuous and mildly calcified mid right coronary artery.A 1.2mm x 12mm threader balloon catheter was advanced for dilation.After it crossed the lesion, the device was taken out of the body and a 6f guide extension catheter was added.Upon reinsertion of the device, the delivery catheter was fractured approximately 8 to 10cm from distal tip when traversing up wire.The device was completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.The 99% stenosed, 12mmx4mm, focal target lesion was located in the moderately tortuous and mildly calcified mid right coronary artery.A 1.2mm x 12mm threader balloon catheter was advanced for dilation.After it crossed the lesion, the device was taken out of the body and a 6f guide extension catheter was added.Upon reinsertion of the device, the delivery catheter was fractured approximately 8 to 10cm from distal tip when traversing up wire.The device was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
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 a kink 32.7cm distal from the strain relief.There was a complete separation at 5mm distal of the proximal end of the balloon.There was contrast in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.Microscopic inspection revealed tip damage.The inner and outer shaft was stretched down in several areas.The inner shaft was buckled for 5mm starting 3mm distal of the separation.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 11373379
• Report Number: 2134265-2021-02279
• Device Sequence Number: 17087348
• Product Code: LOX
• UDI-Device Identifier: 08714729848134
• UDI-Public: 08714729848134
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K134031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2021

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: 12/02/2022
• Device Model Number: 1865
• Device Catalogue Number: 1865
• Device Lot Number: 0026449862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1