MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP BOSTON SCIENTIFIC CATHETER; MONORAIL PTCA DILATATION CATHETER, ANGIOPLASTY, PERIPHERAL TRANSLUMINAL

Model Number NC EMERGE 3.0X12

Device Problem Break (1069)

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

Event Date 03/11/2019

Event Type  Injury  

Event Description

Pci was performed based on the results of diagnostic coronary angiogram.Left main was engaged with a 6fr ebu 3.5 guide.Lad lesion was crossed with run through wire.Predilation of lad was performed with nc emerge 3.0x12mm balloon.The balloon shaft snapped during inflation and was removed with a 4.0mm gooseneck snare.

• Brand Name: BOSTON SCIENTIFIC CATHETER
• Type of Device: MONORAIL PTCA DILATATION CATHETER, ANGIOPLASTY, PERIPHERAL TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP
• MDR Report Key: 8470414
• MDR Text Key: 140581813
• Report Number: MW5085406
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729846390
• UDI-Public: 08714729846390
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NC EMERGE 3.0X12
• Device Catalogue Number: H7493926712300
• Device Lot Number: 23287833
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/29/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 86 YR
• Patient Weight: 79