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

Model Number	105
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint catheter has not been returned for evaluation.If the device is returned and additional testing is completed that results in a different conclusion, a follow-up mdr will be sent in.As per the report from the user facility/distributor, this device was being used off-label for an unapproved indication.The tyshak ii catheter is approved only for percutaneous transluminal valvuplasty of the pulmonary valve.This catheter was being used for bav.In the report it also stated that an inflation device with pressure gauge was not used as is recommended in the instructions for use.It is now known as to what pressure this catheter was taken to.The burst happened during the second inflation.The first inflation was performed and held for 10 seconds with no issues.There is a warning in the instructions for use that states: "if resistance is felt upon removal, then the balloon, guidewire, and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected.This may be accomplished by firmly grasping the balloon catheter and sheath as a unit and withdrawing both together, using a gentle twisting motion combined with traction".There is also a potential complication/adverse effect noted that states: "potential balloon separation following balloon rupture or abuse and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.Note: there have been infrequent reports of larger diameter balloons bursting circumferentially, possibly due to a combination of tight focal strictures in large vessels.In any instance of a balloon rupture while in use, it is recommended that a sheath be placed over the ruptured balloon prior to withdrawal through the entry site.This can be accomplished by cutting off the proximal end of the catheter and slipping an appropriately sized sheath over the catheter into the entry site.For specific technique, refer to: tegtmeyer, charles j., m.D.& bezirdijan diran r., m.D."removing the stuck, ruptured angioplasty balloon catheter." radiology, volume 139, 231-232, april 1981.A comparative catheter from the same lot as the complaint catheter was tested for rated burst pressure.The labeled rated burst pressure for this catalog number is 2.0 atm.The comparative catheter was immersed in a body temperature water bath and was inflated until failure.The balloon did not burst until 3.5 atm, which is well above the labeled rated burst pressure.
Event or Problem Description
As received from numed's distributor/user facility: "the balloon catheter ruptured during a bav.It then got stuck in the patient, who required surgical intervention.1st inflation was for 10 seconds.Burst occurred during the second inflation.The entire balloon was perceived to have been pulled back into the femoral sheath, however it could not be removed from the sheath.The sheath was extracted from the patient, but the distal half of the balloon remained stuck in the patient's femoral artery.Vascular surgeon was called to intervene.Device was successfully removed by surgeon under surgical technique.On (b)(6) 2019 - in an email from the account :an inflation device with pressure gauge was not used.It was hand inflated with a merit medical 30cc syringe.The 8fr, 25cm terumo introducer was used.The catheter shaft was not kinked.Regarding the patient anatomy: prosthetic aortic valve, iliac stents (hence long sheath).The patient was stable post procedure.A second balloon was not used to complete the procedure".

• 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: 8549804
• Report Number: 1318694-2019-00012
• Device Sequence Number: 373984
• Product Code: LIT
• UDI-Device Identifier: 04046964339202
• UDI-Public: 04046964339202
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K003052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/25/2019

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: 03/31/2022
• Device Model Number: 105
• Device Catalogue Number: PDC529
• Device Lot Number: TT-12512
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 04/25/2019
• 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
• Patient Age: 85 YR
• Patient Weight: 63