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

Model Number	7135
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon deflation failure occurred.The target lesion was located in the distal left anterior descending artery.A 3.00mm x 30mm emerge balloon catheter was advanced for dilation.However, during deflation of the balloon for removal, the balloon would not completely deflate.The device was removed.There were no patient complications reported and the patient was stable.
Event or Problem Description
It was reported that balloon deflation failure occurred.The target lesion was located in the distal left anterior descending artery.A 3.00mm x 30mm emerge balloon catheter was advanced for dilation.However, during deflation of the balloon for removal, the balloon would not completely deflate.The device was removed.There were no patient complications reported and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was contrast in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.The outer shaft was stretched down starting at the midshaft bond and extending 115mm, for 40mm extending proximally from the exit notch, and was also a 4mm section starting 2mm distal of the exit notch.The inner shaft was buckled 66mm for the tip.The distal end of the balloon was prolapsed over the tip.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 10132783
• Report Number: 2134265-2020-06765
• Device Sequence Number: 17091708
• Product Code: LOX
• UDI-Device Identifier: 08714729806431
• UDI-Public: 08714729806431
• 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,Followup
• Report Date (Section B): 07/13/2020

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: 10/17/2022
• Device Model Number: 7135
• Device Catalogue Number: 7135
• Device Lot Number: 0025236093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Initial Date Received by Manufacturer: 05/14/2020
• Supplement Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 06/09/2020
• Supplement Report FDA Received Date: 07/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1