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U.S. Department of Health and Human Services

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

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B. BRAUN INTERVENTIONAL SYSTEMS, INC TYSHAK II® CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
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.
 
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Brand NameTYSHAK II®
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
B. BRAUN INTERVENTIONAL SYSTEMS, INC
824 twelfth avenue
bethlehem PA 18018
MDR Report Key8950106
MDR Text Key156128056
Report Number8950106
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 07/24/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number611929
Device Catalogue Number611929
Device Lot NumberTT-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 FDA07/24/2019
Event Location Hospital
Date Report to Manufacturer08/30/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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