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

Model Number H7493927608350

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2017

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 moderately tortuous and mildly calcified left anterior descending artery.A 3.50mm x 8mm nc emerge® balloon catheter was advanced for dilatation.However, during inflation at 16 atmospheres, the balloon ruptured.The device was completely removed from the patient 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 an nc emerge balloon catheter.The balloon was loosely folded with fluid in the balloon and inflation lumen.Inspection of the device revealed a pinhole that was distal of the distal markerband.Inspection of the remainder of the device revealed no other damage or irregularities.Review of the product specification indicates the rated burst pressure (rbp) of the complaint device.The reported information indicates the device was inflated.There is no indication the device was inflated over rbp.The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and mildly calcified left anterior descending artery.A 3.50mm x 8mm nc emerge® balloon catheter was advanced for dilatation.However, during inflation at 16 atmospheres, the balloon ruptured.The device was completely removed from the patient 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: 7154131
• MDR Text Key: 96126410
• Report Number: 2134265-2017-12890
• 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: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2019
• Device Model Number: H7493927608350
• Device Catalogue Number: 39276-0835
• Device Lot Number: 21265737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2017
• 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