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

Model Number H7493927612350

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the moderately tortuous and severely calcified proximal right coronary artery (rca).A 3.50mm x 12mm nc emerge balloon catheter was advanced for dilation.However, upon inflation at 20 atmospheres for 5 seconds, the balloon ruptured.No segment of the balloon was detached inside the patient after it ruptured.The procedure was completed with a different device.No patient complications were reported and the patient's status was good.

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 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.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 80% stenosed target lesion was located in the moderately tortuous and severely calcified proximal right coronary artery (rca).A 3.50mm x 12mm nc emerge® balloon catheter was advanced for dilation.However, upon inflation at 20 atmospheres for 5 seconds, the balloon ruptured.No segment of the balloon was detached inside the patient after it ruptured.The procedure was completed with a different device.No patient complications were reported and the patient's status was good.

• 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: 6191469
• MDR Text Key: 62906568
• Report Number: 2134265-2016-11814
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: KR
• 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: 12/05/2016

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: 08/31/2018
• Device Model Number: H7493927612350
• Device Catalogue Number: 39276-1235
• Device Lot Number: 19637961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2016
• 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
• Patient Age: 68 YR