XXL XXL/18-2/5.8/75E 14-555

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-05-08 for XXL XXL/18-2/5.8/75E 14-555 manufactured by Medi-tech.

Event Text Entries

[56666] Patient with pulmonary valve stenosis underwent cardiac cath and balloon valvuloplasty. During procedure, the balloon ruptured and could not be deflated. After attempts at removal, it lodged in the right femoral vein. The patient went to surgery for femoral vein exploration and removal of balloon. The patient did well and was changed from out-patient to inpatient status. The valve correction was partially achieved prior to the balloon's rupture.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 89342
• MDR Report Key: 89342
• Date Received: 1997-05-08
• Date of Report: 1997-03-31
• Date of Event: 1997-03-18
• Date Facility Aware: 1997-03-18
• Report Date: 1997-03-31
• Date Reported to FDA: 1997-03-31
• Date Reported to Mfgr: 1997-03-31
• Date Added to Maude: 1997-05-09
• 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: XXL
• Generic Name: BALLOON DILITATION CATHETER
• Product Code: MAD
• Date Received: 1997-05-08
• Model Number: XXL/18-2/5.8/75E
• Catalog Number: 14-555
• Lot Number: 353027
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 88325
• Manufacturer: MEDI-TECH
• Manufacturer Address: 480 PLEASANT ST WATERTOWN MA 02172 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	1997-05-08