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

Model Number	1865
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon ruptured occured.The 100% stenosed target lesion was located in the severly tortous and severly calcified right coronary artery.A 1.2mm x 12mm threader balloon catheter was advanced for dilatation.However, during the third inflation at 10 atmospheres, the balloon ruptured.The procedure was completed with a non-bsc 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 contrast in the inflation lumen, contrast and blood in the balloon, and blood in the guidewire lumen.The balloon was loosely folded.The device was soaked in a water bath for one day to loosen the blood and contrast in the device.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.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon ruptured occurred.The 100% stenosed target lesion was located in the severely tortuous and severely calcified right coronary artery.A 1.2mm x 12mm threader balloon catheter was advanced for dilatation.However, during the third inflation at 10 atmospheres, the balloon ruptured.The procedure was completed with a non-bsc device.No patient complications were 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: 8714657
• Report Number: 2134265-2019-07170
• Device Sequence Number: 16576550
• Product Code: LOX
• UDI-Device Identifier: 08714729848134
• UDI-Public: 08714729848134
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K134031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2019

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: 05/28/2020
• Device Model Number: 1865
• Device Catalogue Number: 1865
• Device Lot Number: 0022179512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 08/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1