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	07/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device eval by manufacturer? - it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the balloon burst.A 1.2mm x 12mm threader balloon catheter was selected for a procedure in the coronary artery.After crossing the lesion, dilatation was performed approximately three times.However, the pressure became unable to increase part way through and the balloon ruptured.The device was able to be removed from the patient without issue.The procedure was completed using a different device.There were no patient adverse effects.

• 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: 7730819
• Report Number: 2134265-2018-60004
• Device Sequence Number: 1405303
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/30/2018

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: 12/31/2018
• Device Model Number: 1865
• Device Catalogue Number: 1865
• Device Lot Number: 0020109652
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2018
• Initial Report FDA Received Date: 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1