MAUDE Adverse Event Report: B. BRAUN INTERVENTIONAL SYSTEMS, INC TYSHAK II®; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number 611929

Device Problems Burst Container or Vessel (1074); Inflation Problem (1310); Material Puncture/Hole (1504)

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

Event Date 07/12/2019

Event Type  malfunction  

Event Description

Valvuloplasty balloon was inflated and then burst.It is believed that the balloon ruptured due to the heavy calcium on the patient's valve which poked a hole in the plastic of the balloon.

• Brand Name: TYSHAK II®
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): B. BRAUN INTERVENTIONAL SYSTEMS, INC; 824 twelfth avenue; bethlehem PA 18018
• MDR Report Key: 8950106
• MDR Text Key: 156128056
• Report Number: 8950106
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/24/2019

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 Model Number: 611929
• Device Catalogue Number: 611929
• Device Lot Number: TT-13460
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/24/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 32850 DA