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

Model Number	7130
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No event date provided, used the first date of the month of the aware date 01oct2018.
Event or Problem Description
Reportable based on device analysis completed on 04oct2018.This 3.00mm x 8mm emerge balloon catheter was received with no reported issues.However, returned device analysis revealed separated hypotube.Device evaluated by manufacturer: the returned product consisted of an emerge balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple kinks along the hypotube.The hypotube is separated 79.6cm from the hub.Microscopic examination revealed that the tip is damaged and the balloon is loose.There is blood present in the hub, inflation lumen, and balloon.The broken shaft was connected to a tuohy adapter and stopcock then inflated using a balloon inflation device to check for possible damages to the balloon.The balloon was inflated to rbp of 14atm and could hold pressure for 5 minutes before it was deflated.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: 8005690
• Report Number: 2134265-2018-62303
• Device Sequence Number: 1190327
• Product Code: LOX
• UDI-Device Identifier: 08714729806547
• UDI-Public: 08714729806547
• Combination Product (Y/N): N
• PMA/510(K) Number: K113220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/25/2018

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: 11/18/2020
• Device Model Number: 7130
• Device Catalogue Number: 7130
• Device Lot Number: 0021905159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1