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	01/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the left anterior descending artery.A 1.50mm x 8mm and a 2.50mm x 15mm emerge balloon catheters were selected to perform kissing balloon technique.However, both devices had difficulty advancing through the guide catheter and the shaft broke on both balloons.The procedure was completed with another bsc balloon catheter.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
The device was evaluated by mfr: returned product consisted of an emerge balloon catheter in two pieces.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast in the inflation lumen and blood in the guidewire lumen.The balloon was tightly folded.Inspection of the device revealed that there were numerous kinks throughout the hypotube with a complete hypotube separation 24cm distal of the strain relief.The hypotube fracture surfaces were ovaled, which suggests the device was kinked prior to separation.The tip was also damaged.The guide catheter used in the procedure were not returned for analysis, so a 6f test guide catheter was used for functional testing.The distal portion of this device and the distal portion of the related complaint were able to fit and advance through the guide up to the kinks and separation with no issues.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the left anterior descending artery.A 1.50mm x 8mm and a 2.50mm x 15mm emerge balloon catheters were selected to perform kissing balloon technique.However, both devices had difficulty advancing through the guide catheter and the shaft broke on both balloons.The procedure was completed with another bsc balloon catheter.No patient complications nor injuries were 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: 9695686
• Report Number: 2134265-2020-01175
• Device Sequence Number: 2755993
• Product Code: LOX
• UDI-Device Identifier: 08714729806493
• UDI-Public: 08714729806493
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K121196
• 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,Followup
• Report Date (Section B): 03/11/2020

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: 10/24/2021
• Device Model Number: 7130
• Device Catalogue Number: 7130
• Device Lot Number: 0023407980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 03/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON CATHETER: EMERGE 2.50MM X 15MM; BALLOON CATHETER: EMERGE 2.50MM X 15MM