OWENS VALVULOPLASTY BALLOON DILATATION CATHETER 2617

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-09-22 for OWENS VALVULOPLASTY BALLOON DILATATION CATHETER 2617 manufactured by A Division Of Boston Scientific Corp..

Event Text Entries

[71920] A balloon ruptured and separated from the catheter shaft during an unknown procedure on a pediatric pt. All of the detached segments were successfully retrieved. The procedure was successfully completed and the pts condition was reported as fine. Attempts to gain further details with regards to the circumstances surrounding this event were unsuccessful. This device was received, evaluated and retained by this mfr. The engineering evaluation indicated the balloon catheter was returned in two sections. A portion of the balloon material and the tip of the catheter was detached and not returned for evaluation. A kink was located in the catheter shaft approximately 1 centimeter proximal to the proximal bond in addition to longitudinal gouges in the shaft. The central lumen of the catheter was extended approximately 9 centimeters from beyond the balloon section at the proximal end of the catheter. The balloon material was detached approximately 3 centimeters from the proximal bond and the edges of the balloon material appeared uneven. Microscopic examination of the returned portion of the balloon material revealed severe scratches and gouges running circumfrentially around the balloon. Examination of the distal end of the central lumen revealed it was frayed and necked down. The proximal balloon bond was intact. Examination of the tip indicated it was severly damaged, torn, stretched, gouged and damaged. Grove marks were located on the tip. A guidewire which extended approximately 8 millimeters from the end of the tip and approximately 6 millimeters from the proximal end of the tip was severely damaged, bent with coils twisted and bent. This device displayed characteristics consistent with exertion against resistance, necking of the catheter shaft and a torn and stretched tip, as well as contact with a sharp external source, gouges in the catheter shaft and scratches and gouges in the balloon. This balloon catheter was used on a pediatric pt for an uknown procedure. This device is not indicated for pediatric use. Co feels these factors may have contributed to this event. However without further details we are unable to determine the exact cause for this event.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1220563-1997-00007
• MDR Report Key: 121472
• Report Source: 05
• Date Received: 1997-09-22
• Date of Report: 1997-08-25
• Date of Event: 1997-08-22
• Date Reported to FDA: 1997-09-22
• Date Mfgr Received: 1997-08-25
• Device Manufacturer Date: 1997-04-01
• Date Added to Maude: 1997-09-24
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• 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: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: OWENS VALVULOPLASTY BALLOON DILATATION CATHETER
• Generic Name: VALVULOPLASTY BAL CATH
• Product Code: MAD
• Date Received: 1997-09-22
• Returned To Mfg: 1997-09-10
• Model Number: NA
• Catalog Number: 2617
• Lot Number: 602319
• ID Number: NA
• Device Expiration Date: 1999-05-15
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: NA
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 118983
• Manufacturer: A DIVISION OF BOSTON SCIENTIFIC CORP.
• Manufacturer Address: 31 MAPLE ST. MILFORD MA 01757 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1997-09-22