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

Model Number	7211
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the calcified proximal and mid circumflex artery.After rotablation was successfully performed, a 2.5 x 30mm emerge balloon catheter was advanced for predilation.A 2.75 x 38mm promus premier drug-eluting stent (des) was deployed for treatment.After stenting, the mid portion of the stent needed to be post dilated.A 3.00mm x 8mm nc emerge balloon catheter was then advanced for post dilation.However, during inflation the balloon ruptured.The device was removed and a 3.00mm x 12mm nc emerge balloon catheter was used but the balloon also ruptured.During removal, it was noted that the distal portion of the balloon sheared off on the wire.The guide and wire was removed, leaving a portion of the balloon in the proximal circumflex.After multiple failed attempts to removed it, the physician decided to stent it in place with a 3.0 x 24mm promus premier des and the procedure was completed.Post procedure timi 3 flow with no obstruction was observed.No patient complications were reported and the patient's status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the calcified proximal and mid circumflex artery.After rotablation was successfully performed, a 2.5 x 30mm emerge balloon catheter was advanced for predilation.A 2.75 x 38mm promus premier drug-eluting stent (des) was deployed for treatment.After stenting, the mid portion of the stent needed to be post dilated.A 3.00mm x 8mm nc emerge balloon catheter was then advanced for post dilation.However, during inflation the balloon ruptured.The device was removed and a 3.00mm x 12mm nc emerge balloon catheter was used but the balloon also ruptured.During removal, it was noted that the distal portion of the balloon sheared off on the wire.The guide and wire was removed, leaving a portion of the balloon in the proximal circumflex.After multiple failed attempts to removed it, the physician decided to stent it in place with a 3.0 x 24mm promus premier des and the procedure was completed.Post procedure timi 3 flow with no obstruction was observed.No patient complications were reported and the patient status was stable.It was further reported that the target lesion was 70 to 80% stenosed, located in the moderately tortuous and severely calcified proximal and mid circumflex artery.The balloons were inflated 3-4 times and at around 14-15 atmospheres in each inflations.There was no issue with the 2.75 x 38mm promus premier stent.Returned product consisted of a nc emerge balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed kinks along the hypotube at 7.8cm and 34cm from the hub.Microscopic examination revealed a longitudinal tear on the inflation lumen 20mm long and 13mm from the tip.The balloon is loosely folded and pulled over the tip of the device.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: 7882570
• Report Number: 2134265-2018-61052
• Device Sequence Number: 2489337
• Product Code: LOX
• UDI-Device Identifier: 08714729846260
• UDI-Public: 08714729846260
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 10/23/2018

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: 07/18/2020
• Device Model Number: 7211
• Device Catalogue Number: 7211
• Device Lot Number: 0022394454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1