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

Model Number H7493926712350

Device Problems Break (1069); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/17/2019

Event Type  Injury  

Event Description

A 6 french xb lad 3.5 guide was engaged in the ostium of the left main artery.A 3.5 x 12 mm nc emerge mr balloon was prepped and advanced across the proximal lad, then inflated to 12 atm in 21 seconds.Thirty seconds later, the distal end of the balloon shaft broke off, which left the balloon in the proximal left anterior descending (lad).At this point, the patient did describe chest pain, but did not have any st-t wave abnormalities or hemodynamic issues.The doctor advanced a long run wire into the apical lad.Ten minutes later, another compliant balloon was advanced into the proximal lad, inflated to 5 atm and used to trap the broken balloon and pull it back into the guide catheter.At that point, both balloons were safely removed from the patient.The balloon was not inflated to or above its rated burst pressure at any point (20 atm).The operator applied an even, smooth amount of pressure as to not force a kink of the catheter.The fact that the non-compliant balloon dilatation catheter failed, so catastrophically as to fragment and leave a segment behind is unacceptable.Fortunately, the interventional cardiologist/fellow was able to successfully retrieve all of the pieces of the balloon catheter shaft fracture and no harm was caused to the patient.

• Brand Name: NC EMERGE®
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8695369
• MDR Text Key: 147909635
• Report Number: 8695369
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/31/2019,05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H7493926712350
• Device Catalogue Number: H7493926712350
• Device Lot Number: 23287834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/31/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 23360 DA
• Patient Weight: 88