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

Model Number	7133
Medical Device Problem Codes	Inflation Problem (1310); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 and blood in the inflation lumen and balloon.The balloon was tightly folded.Microscopic inspection revealed tip damage.The device was soaked in a water bath for one hour to loosen the blood and contrast in the device.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There was a longitudinal tear 3mm long starting 17mm distally from the exit notch.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2020.It was reported that inflation failure and shaft kink occurred.The 80% stenosed target lesion was located in severely tortuous and severely calcified right coronary artery.A 3.50mm x 15mm emerge balloon catheter was advanced for dilatation.However, when inflation was attempted, the balloon failed to inflate.The device was removed and a kink was noticed proximal to the balloon.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.However, returned device analysis revealed a shaft tear.

• 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: 10617552
• Report Number: 2134265-2020-13630
• Device Sequence Number: 3885423
• Product Code: LOX
• UDI-Device Identifier: 08714729806257
• UDI-Public: 08714729806257
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 10/01/2020

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: 07/17/2022
• Device Model Number: 7133
• Device Catalogue Number: 7133
• Device Lot Number: 0024799505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 10/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1