MEDITECH XXL * 14-510

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-02-21 for MEDITECH XXL * 14-510 manufactured by Mediotech - Boston Scientific Corp..

Event Text Entries

[46283] Pt was undergoing balloon valvuloplasty of the pulmonary homograft and balloon ruptured during inflation. Calcification of the outflow tract may have caused balloon rupture.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 71527
• MDR Report Key: 71527
• Date Received: 1997-02-21
• Date of Report: 1997-01-23
• Date of Event: 1997-01-14
• Date Facility Aware: 1997-01-14
• Date Added to Maude: 1997-02-28
• 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
• Reporter Occupation: RISK MANAGER
• 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 Sequence Number: 1

• Brand Name: MEDITECH XXL
• Generic Name: BALLOON DILATATION CATHETER
• Product Code: MAD
• Date Received: 1997-02-21
• Model Number: *
• Catalog Number: 14-510
• Lot Number: 331824
• ID Number: XXL/12-4/5.8/75
• Device Expiration Date: 1999-05-28
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 71418
• Manufacturer: MEDIOTECH - BOSTON SCIENTIFIC CORP.
• Manufacturer Address: 480 PLEASANT ST WATERTOWN MA 02172 US

Device Sequence Number: 2

• Brand Name: MEDIITEC XXL
• Generic Name: BALLOON DILATATION CATHETER
• Product Code: LIT
• Date Received: 1997-02-21
• Model Number: *
• Catalog Number: 14-510
• Lot Number: 331824
• ID Number: XXL/12-4/5.8/75
• Device Expiration Date: 1999-05-28
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 2
• Device Event Key: 71421
• Manufacturer: MEDIOTECH - BOSTON SCIENTIFIC CORP.
• Manufacturer Address: 480 PLEASANT ST WATERTOWN MA 02172 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1997-02-21