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

Model Number	7134
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a coronary vessel.A 1.50mm x 20mm emerge balloon catheter was advanced for dilatation.However, the physician noted that the balloon and the catheter "shredded" while in the vessel.When the device was removed from the vessel to the guide catheter, it was noted that the catheter's external layer had came off and dislodged inside the guide catheter.The physician used another balloon to trap the loose material in the guide catheter and then removed everything as a unit.The physician took pictures and confirmed that nothing was left behind.The procedure was rescheduled for later date using atherectomy.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a coronary vessel.A 1.50mm x 20mm emerge balloon catheter was advanced for dilatation.However, the physician noted that the balloon and the catheter "shredded" while in the vessel.When the device was removed from the vessel to the guide catheter, it was noted that the catheter's external layer had came off and dislodged inside the guide catheter.The physician used another balloon to trap the loose material in the guide catheter and then removed everything as a unit.The physician took pictures and confirmed that nothing was left behind.The procedure was rescheduled for later date using atherectomy.The device was returned for evaluation.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination observed that the inflation lumen is separated at 122.2cm from the hub.The distal section of the separated inflation lumen is stretched and has multiple kinks.There are multiple other kinks along the rest of the device.The balloon is separated at 2.9cm from the tip.The distal section of the separated balloon is bunched up towards the tip of the balloon.Microscopic examination revealed that the tip is damaged.There is blood present in the hub, inflation lumen, guidewire lumen, and balloon.The balloon is loose.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: 7952454
• Report Number: 2134265-2018-61788
• Device Sequence Number: 13503605
• Product Code: LOX
• UDI-Device Identifier: 08714729806295
• UDI-Public: 08714729806295
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/23/2020
• Device Model Number: 7134
• Device Catalogue Number: 7134
• Device Lot Number: 0021791573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Initial Date Received by Manufacturer: 09/17/2018
• Supplement Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention