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

Model Number	7211
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/17/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that removal difficulties were encountered, balloon rupture and balloon detachment occurred.The target lesion was located in the left anterior descending artery.A 3.00mm x 8mm nc emerge balloon catheter was advanced and pre-dilated the lesion.After stent placement, the same balloon was used for post dilation.However, upon inflation at 24 atmospheres, the balloon ruptured and became stuck in the vessel.After multiple removal attempts, they were able to remove it and when they did, the balloon material and the balloon markers sheared off and were left in the patient.A snaring attempt was made to retrieve the balloon material that was left in the patient's body but it could not be removed.A couple more stents were used and they stented the material up against the vessel wall and left it.The procedure was completed with a different device.No further patient complications were reported and the patient did fine throughout the procedure and was discharged.
Event or Problem Description
It was reported that removal difficulties were encountered, balloon rupture and balloon detachment occurred.The target lesion was located in the left anterior descending artery.A 3.00mm x 8mm nc emerge balloon catheter was advanced and pre-dilated the lesion.After stent placement, the same balloon was used for post dilation.However, upon inflation at 24 atmospheres, the balloon ruptured and became stuck in the vessel.After multiple removal attempts, they were able to remove it and when they did, the balloon material and the balloon markers sheared off and were left in the patient.A snaring attempt was made to retrieve the balloon material that was left in the patient's body but it could not be removed.A couple more stents were used and they stented the material up against the vessel wall and left it.The procedure was completed with a different device.No further patient complications were reported and the patient did fine throughout the procedure and was discharged.Device evaluated by mfr: returned product consisted of an nc emerge balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual and microscopic examination revealed that the distal section of the device is missing.The balloon, distal guidewire lumen, marker band, and tip were not returned.The shaft appeared to be stretched prior to separation.There are multiple kinks along the whole device.There is blood present in the guidewire lumen, inflation lumen, and hub.The review of the product specification indicates the rated burst pressure (rbp) of the complaint device is 20 atm.The reported information indicates the device was inflated to 24atm; therefore, the device was inflated over rbp.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: NC 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: 7860342
• Report Number: 2134265-2018-60824
• Device Sequence Number: 11124134
• Product Code: LOX
• UDI-Device Identifier: 08714729846260
• UDI-Public: 08714729846260
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141236
• 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): 10/25/2018

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: 06/26/2019
• Device Model Number: 7211
• Device Catalogue Number: 7211
• Device Lot Number: 0020813261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 09/10/2018
• Supplement 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
• Outcome Attributed to Adverse Event: Required Intervention