MAUDE Adverse Event Report: BOSTON SCIENTIFIC EMERGE PTCA DILATATION CATHETER

Catalog Number	H7493918920350
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/28/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Ccl boston scientific ptca ruptured during inflation in coronary artery, removed, new item obtained to complete cath.

• Brand Name: EMERGE PTCA DILATATION CATHETER
• Common Device Name: PTCA DILATATION CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC ; marlborough MA 01752
• MDR Report Key: 6547658
• Report Number: MW5069592
• Device Sequence Number: 19024561
• Product Code: LOX
• UDI-Device Identifier: 08714729806363
• UDI-Public: (01)08714729806363(17)190831(10)
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/03/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: H7493918920350
• Device Lot Number: 20097377
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR