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

Model Number	7211
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break occurred.A 3.00mm x 8mm nc emerge balloon catheter was advanced for dilatation.When the device was removed, it was noted that the shaft was broken 20cm from the hub.The detached part was removed using a snare.The procedure was completed with this device.No patient harm nor complications were reported.
Additional Manufacturer Narrative
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 multiple kinks along the hypotube and the hypotube is separated 36.9cm from the hub.Microscopic examination revealed damage to the tip.There is blood present on the balloon folds and inside the tip.The balloon is still tightly folded.
Event or Problem Description
It was reported that shaft break occurred.A 3.00mm x 8mm nc emerge balloon catheter was advanced for dilatation.When the device was removed, it was noted that the shaft was broken 20cm from the hub.The detached part was removed using a snare.The procedure was completed with this device.No patient harm nor complications were reported.

• 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: 8420592
• Report Number: 2134265-2019-02406
• Device Sequence Number: 2170860
• Product Code: LOX
• UDI-Device Identifier: 08714729846260
• UDI-Public: 08714729846260
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 04/10/2019

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: 12/10/2020
• Device Model Number: 7211
• Device Catalogue Number: 7211
• Device Lot Number: 23068545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 04/10/2019
• 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
• Patient Age: 78 YR