MAUDE Adverse Event Report: NUMED, INC. TYSHAK II CATHETER; PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER

Model Number	105
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record was performed and no issues were found.All devices within the lot met all requirements for release and distribution.There have been no other complaints associated with this lot number.A review of the balloon material used shows there are no other complaints associated with the balloon material used to manufacture the balloons used on this lot of catheters.The catheter was returned in a biohazard bag.The catheter is bloody.The introducer is still on the catheter.There is a circumferential tear in the balloon.The proximal end of the balloon has been pulled back to the proximal end of the introducer.The distal end of the balloon, which is inverted, is lodged in the distal end of the introducer.The inner tubing is stretched, but intact.The catheter is whole with no pieces missing from the device.The report from the distributor stated that a partial cut down of the femoral vein was performed to locate and remove a distal balloon fragment, however, the device was not missing any pieces when it was returned to numed for investigation.A comparative catheter was pulled and tested for rated burst pressure.The comparative catheter was the same catalog number but a different lot number as the complaint catheter.The balloon was immersed in a body temperature bath and incrementally inflated until it burst.The catheter did not burst until 4.5 atm, which is well above the labeled rated burst pressure of 2.0 atm and labeled nominal pressure of 1.5 atm.This device was being used off label for an unapproved indication.The approved indication is pulmonary valvuloplasty.The device was being used for a static atrial septostomy procedure.It is likely that this led to the balloon burst.
Event or Problem Description
Per the report from the user facility / distributor - balloon rupture of an 18mm x 5cm tyshak ii balloon inflated to rbp (but not greater than rbp).An inflation device with pressure gauge was used.The indication the physician was using the balloon for was static atrial septostomy.The size and type of introducer sheath being used: 8fr terumo.The rupture was circumferential and the physician could not risk the wire position while on va ecmo, therefore performed a partial cut down of the femoral vein to locate the distal balloon fragment (which had inverted on itself) and removed it.Patient condition post procedure was critical, however not related to the balloon rupture.

• Brand Name: TYSHAK II CATHETER
• Common Device Name: PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• MDR Report Key: 11678262
• Report Number: 1318694-2021-00004
• Device Sequence Number: 3050150
• Product Code: LIT
• UDI-Device Identifier: 04046964339202
• UDI-Public: 04046964339202
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K003052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: 105
• Device Catalogue Number: PDC529
• Device Lot Number: TT-16513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention