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	11/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reported address 1: (b)(4).Initial reporter city: (b)(4).
Event or Problem Description
It was reported that balloon rupture occurred.A 1.2mm x 12mm threader balloon catheter was advanced for dilatation.However, during inflation at nominal pressure, the balloon ruptured.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: 10954555
• Report Number: 2134265-2020-17011
• Device Sequence Number: 11484281
• 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): 12/04/2020

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: 02/11/2022
• Device Model Number: 1860
• Device Catalogue Number: 1860
• Device Lot Number: 0025196482
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 12/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1