MAUDE Adverse Event Report: TORAY INDUSTRIES INOUE PTMC-28; BALLOON FOR VALVULOPLASTY

Model Number KMS-1

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/29/2015

Event Type  malfunction  

Event Description

Pt undergoing valvuloplasty utilizing incue-balloon system.Balloon ruptured during inflation in pt's mitral valve area.Unsure if rupture due to valve physiology or balloon functioning as designed.

• Brand Name: INOUE PTMC-28
• Type of Device: BALLOON FOR VALVULOPLASTY
• Manufacturer (Section D): TORAY INDUSTRIES; chuo-ku; tokyo ; JA
• MDR Report Key: 5191305
• MDR Text Key: 30032431
• Report Number: MW5057551
• Device Sequence Number: 1
• Product Code: OZT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/27/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2016
• Device Model Number: KMS-1
• Device Lot Number: 141126
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/27/2015
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 32 YR