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

Model Number	7133
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 95% stenosed target lesion was located in the thrombosed proximal to mid left anterior descending artery.A 3.00mm x 15mm emerge balloon catheter was advanced for dilatation.However, during the procedure, the balloon shaft snapped in half.The device was completely removed from the patient's body and the procedure was completed with another of the same device.There were no patient complications reported.
Event or Problem Description
It was reported that shaft break occurred.The 95% stenosed target lesion was located in the thrombosed proximal to mid left anterior descending artery.A 3.00mm x 15mm emerge balloon catheter was advanced for dilatation.However, during the procedure, the balloon shaft snapped in half.The device was completely removed from the patient's body and the procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an emerge balloon catheter in two pieces.The balloon was tightly folded.Analysis of the balloon, inner/outer shaft, and hypotube included microscopic and visual inspection.Inspection revealed a separation in the hypotube located 69cm from the strain relief and there were numerous kinks in the hypotube.The fracture faces of the separated ends were ovalized, as if kinked prior to separating.

• 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: 9583079
• Report Number: 2134265-2019-16730
• Device Sequence Number: 491184
• Product Code: LOX
• UDI-Device Identifier: 08714729806233
• UDI-Public: 08714729806233
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 02/18/2020

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: 06/11/2022
• Device Model Number: 7133
• Device Catalogue Number: 7133
• Device Lot Number: 0024596587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Initial Date Received by Manufacturer: 12/27/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1