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

Model Number H7493926715550

Device Problem Material Perforation (2205)

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

Event Date 06/24/2020

Event Type  malfunction  

Event Description

Patient had a difficult lesion in the lad.A 6 french ebu 3.0 guide was used to engage the left coronary artery.The lad was crossed using a run-through wire.Predilation was performed using a 2.0 compliant balloon, a 2.5 noncompliant balloon with balloon perforation and balloon was fully withdrawn.No residual pieces left behind.

• Brand Name: NC EMERGE
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10349530
• MDR Text Key: 201168294
• Report Number: 10349530
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: H7493926715550
• Device Catalogue Number: H7493926715550
• Device Lot Number: 25309782
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/10/2020
• Event Location: Other
• Date Report to Manufacturer: 07/31/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17520 DA