MANSFIELD 2616

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-11-02 for MANSFIELD 2616 manufactured by Boston Scientific Corp..

Event Text Entries

[17416213] Procedure pericardiocentesis. During inflation of the balloon, a transverse rupture occurred. When the balloon was removed, the distal aspect remained within the pericardium. Attempts at retrieval were made using snares and forceps device, without success, surgical consult obtained for completion of the pericardial window procedure and retrieval of the balloon fragment which remained on a 0. 38 wire. Fragment removed surgically without harm to pt 10/20/94.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 18837
• MDR Report Key: 18837
• Date Received: 1994-11-02
• Date of Report: 1994-10-27
• Date of Event: 1994-10-20
• Date Facility Aware: 1994-10-20
• Report Date: 1994-10-27
• Date Reported to FDA: 1994-10-27
• Date Reported to Mfgr: 1994-10-27
• Date Added to Maude: 1995-01-09
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MANSFIELD
• Generic Name: VALVULOPLASTY BALLOON
• Product Code: MAD
• Date Received: 1994-11-02
• Returned To Mfg: 1994-10-21
• Catalog Number: 2616
• Lot Number: 505047
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: *
• Implant Flag: N
• Date Removed: B
• Device Sequence No: 1
• Device Event Key: 18765
• Manufacturer: BOSTON SCIENTIFIC CORP.
• Manufacturer Address: WATERTOWN MA 02172 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	1994-11-02