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

Model Number	7211
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/29/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 07-nov-2018.It was reported that shaft kink occurred.The target lesion was located in a coronary artery.A 4.00mm x 8mm nc emerge balloon catheter was advanced for dilation, but the balloon delivery shaft was noted to be kinked.The procedure was completed with another of same device.No patient complications were reported and the patient was stable.However, returned device analysis revealed a hypotube separation.Device evaluated by manufacturer: the returned product consisted of a nc emerge balloon catheter in two pieces.The balloon was loosely folded.The outer shaft, inner shaft, balloon and tip were microscopically examined.The hypotube was completely separated 41.3cm from the hub.The hypotube fracture surfaces were ovaled and torn, which suggests the device was kinked prior to separation.There are numerous hypotube and shaft kinks.The 3mm of the shaft is torn starting at the exit notch, which is consistent with damage seen with the use of a guidewire.Inspection of the remainder of the device presented no other damage or irregularities.There was no evidence of any material or manufacturing deficiencies contributing to the damage and the reported event.

• 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: 8116983
• Report Number: 2134265-2018-63336
• Device Sequence Number: 16454834
• Product Code: LOX
• UDI-Device Identifier: 08714729846307
• UDI-Public: 08714729846307
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/29/2018

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: 03/31/2019
• Device Model Number: 7211
• Device Catalogue Number: 7211
• Device Lot Number: 0020407762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 11/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1