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

Model Number	7130
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned product consisted of an emerge balloon catheter.The balloon was tightly folded with blood in the wire lumen.There were numerous hypotube kinks.The hypotube was separated 24.5cm from the hub.The separated ends of the hypotube was ovaled indicating the hypotube was kinked prior to separating.
Event or Problem Description
It was reported that shaft break occurred.The chronic totally occluded target lesion was located in the severely calcified right coronary artery.A 2.00mm x 8mm emerge balloon catheter was advanced for dilatation.There were two balloons in the guide catheter and while pushing, the shaft kinked and when pulled back, the shaft broke about 6 inches from the hub.The device was removed and the procedure was completed with another of the same device.There were no patient complications reported.

• Brand Name: EMERGE
• Common Device Name: CATHETERS TRANSLUMINAL CORONARY ANGIOPLASTY PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9746012
• Report Number: 2134265-2020-02008
• Device Sequence Number: 14074263
• Product Code: LOX
• UDI-Device Identifier: 08714729806509
• UDI-Public: 08714729806509
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K113220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/24/2020

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: 06/12/2022
• Device Model Number: 7130
• Device Catalogue Number: 7130
• Device Lot Number: 0024604026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 02/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR