MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE NC EMERGE® CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number H7493927615300

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2016

Event Type  malfunction  

Manufacturer Narrative

Age at time of event : 18 years or older. (b)(4).

Event Description

It was reported that balloon rupture occurred. The 90% stenosed target lesion was located in the severely calcified coronary artery. A 3. 00mm x15mm nc emerge® balloon catheter was advanced for dilation. When the balloon was inflated below nominal pressure, the balloon ruptured. The device was completely removed from the patient's body. The procedure was completed using with a different device. No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of an nc emerge balloon catheter. The balloon was loosely folded with contrast and blood in the balloon and lumen. There was blood in the wire lumen. There were numerous hypotube kinks. The balloon, markerbands, proximal bond and tip were microscopically examined. A longitudinal tear was identified in the balloon wall. Microscopic examination of the balloon presented no irregularities in the balloon material, markerband and proximal bond that could have contributed to the damage. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The most probable root cause is operational context as device performance was limited due to anatomical procedural factors. (b)(4).

Event Description

It was reported that balloon rupture occurred. The 90% stenosed target lesion was located in the severely calcified coronary artery. A 3. 00mm x15mm nc emerge® balloon catheter was advanced for dilation. When the balloon was inflated below nominal pressure, the balloon ruptured. The device was completely removed from the patient's body. The procedure was completed using with a different device. No patient complications were reported.

• Brand Name: NC EMERGE®
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6190680
• MDR Text Key: 62915148
• Report Number: 2134265-2016-12063
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/08/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/30/2018
• Device Model Number: H7493927615300
• Device Catalogue Number: 39276-1530
• Device Lot Number: 19748256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial