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

Model Number	7212
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	09/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the non-tortuous and severely calcified left main (lm) artery.A 3.00mm x 12mm nc emerge balloon catheter was advanced for dilatation.However, during the first inflation at nominal pressure, the balloon ruptured.The ruptured balloon occluded flow in the lm and the patient went into pulseless electrical activity (pea).The balloon was removed completely, and the procedure was completed with a stent.The patient status post-procedure was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an nc emerge balloon catheter.The device was visually and microscopically examined.There was contrast and blood in the inflation lumen and the balloon.There was blood in the guidewire lumen and the balloon was loosely folded.At 3mm distal from the proximal markerband, there was a full circumferential tear.Product analysis confirmed the reported burst, as there was a full circumferential tear.
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the non-tortuous and severely calcified left main (lm) artery.A 3.00mm x 12mm nc emerge balloon catheter was advanced for dilatation.However, during the first inflation at nominal pressure, the balloon ruptured.The ruptured balloon occluded flow in the lm and the patient went into pulseless electrical activity (pea).The balloon was removed completely, and the procedure was completed with a stent.The patient status post-procedure was stable.

• Brand Name: NC EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17961597
• Report Number: 2124215-2023-55861
• Device Sequence Number: 7036002
• Product Code: LOX
• UDI-Device Identifier: 08714729846390
• UDI-Public: 08714729846390
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/19/2025
• Device Model Number: 7212
• Device Catalogue Number: 7212
• Device Lot Number: 0031857674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/25/2023
• Supplement Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown