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

Model Number	7130
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The 99% stenosed target lesion was located in the right coronary artery.A 6fr jr4 non-bsc guide catheter was used and a 180cm non-bsc guide wire was advanced to cross the lesion.A 1.50mm x 8mm emerge balloon catheter was advanced for dilatation; however, it was noted that the shaft was fractured.The procedure was completed with a different device.No patient complications were reported and the patient's status was fine.
Event or Problem Description
It was reported that shaft break occurred.The 99% stenosed target lesion was located in the right coronary artery.A 6fr jr4 non-bsc guide catheter was used and a 180cm non-bsc guide wire was advanced to cross the lesion.A 1.50mm x 8mm emerge balloon catheter was advanced for dilatation; however, it was noted that the shaft was fractured.The procedure was completed with a different device.No patient complications were reported and the patient's status was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: 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 71.5cm from the hub.Microscopic examination revealed no additional damages.There is blood present in the guide wire lumen and the balloon is still tightly folded.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: 8176917
• Report Number: 2134265-2018-64365
• Device Sequence Number: 19519293
• Product Code: LOX
• UDI-Device Identifier: 08714729806493
• UDI-Public: 08714729806493
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K121196
• 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): 02/04/2019

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: 08/08/2020
• Device Model Number: 7130
• Device Catalogue Number: 7130
• Device Lot Number: 0021506017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 02/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1