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

Model Number H7493927615250

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that balloon rupture occurred.The target lesion was located in a moderately tortuous and severely calcified vessel.A 2.50mm x 15mm nc emerge® balloon catheter was advanced for dilatation.However, during the second inflation at 20 atmospheres, the balloon ruptured.The device was completely removed from the patient's body and the procedure was completed with a different device.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a nc emerge balloon catheter.There was contrast and blood in the inflation lumen and balloon.The balloon was loosely folded.There were numerous hypotube kinks and the tip was damaged.Microscopic examination of the balloon revealed a 4.5cm longitudinal tear in the balloon wall at the distal end of the balloon.Microscopic examination presented no irregularities in the balloon material or markerbands that could have contributed to the damage.There is no indication the device was inflated over rated burst pressure.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 target lesion was located in a moderately tortuous and severely calcified vessel.A 2.50mm x 15mm nc emerge® balloon catheter was advanced for dilatation.However, during the second inflation at 20 atmospheres, the balloon ruptured.The device was completely removed from the patient's body and the procedure was completed with a different device.No patient complications were reported and the patient's status was stable.

• 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: 6189520
• MDR Text Key: 62856156
• Report Number: 2134265-2016-11960
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2016

1 Device was Involved in the Event

1 Patient was 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: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: H7493927615250
• Device Catalogue Number: 39276-1525
• Device Lot Number: 0018973546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1