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

Model Number	1860
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.A 1.2mm x 12mm threader balloon catheter was selected for use for a percutaneous coronary intervention (pci) procedure in the mid left anterior descending artery (lad).The target lesion was 100% stenosed.The balloon was unable to cross the lesion area completely, but dilatation was started at the area just before reaching the lesion.The pressure decreased before reaching the nominal pressure, and it was then confirmed that the balloon ruptured.The device was then removed successfully and the procedure was completed using a different balloon catheter.There were no patient complications 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: 8383034
• Report Number: 2134265-2019-01917
• Device Sequence Number: 16206457
• Product Code: LOX
• UDI-Device Identifier: 08714729848127
• UDI-Public: 08714729848127
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/01/2019

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: 10/03/2020
• Device Model Number: 1860
• Device Catalogue Number: 1860
• Device Lot Number: 22746721
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 03/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1