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

Model Number	7134
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter entrapment and shaft break occurred.A 3.00mm x 20mm emerge balloon catheter was advanced for dilation; however, the balloon became stuck in the bmw guide wire.Both devices were removed together from the patient's body and when tried to remove the balloon from the wire, the balloon shaft broke.The procedure was completed with a different device.No patient complications were reported.
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 a complete separation at 106.2cm distal of the strain relief.There was blood in the guidewire lumen.The balloon was loosely folded.Microscopic inspection revealed tip damage.The inner was stretched down starting 54mm from the tip and extending 5mm, and at 36mm extending 15mm.The inner shaft was buckled for 9mm starting 9mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that catheter entrapment and shaft break occurred.A 3.00mm x 20mm emerge balloon catheter was advanced for dilation; however, the balloon became stuck in the bmw guide wire.Both devices were removed together from the patient's body and when tried to remove the balloon from the wire, the balloon shaft broke.The procedure was completed with a different device.No patient complications 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: 10401177
• Report Number: 2134265-2020-10259
• Device Sequence Number: 3093683
• Product Code: LOX
• UDI-Device Identifier: 08714729806349
• UDI-Public: 08714729806349
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/28/2020

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: 07/24/2022
• Device Model Number: 7134
• Device Catalogue Number: 7134
• Device Lot Number: 0024838928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Initial Date Received by Manufacturer: 07/22/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 09/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1