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	07/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not returned to numed for evaluation.The device was being used off-label for an unapproved indication.This catheter is only indicated for percutaneous valvuloplasty of the pulmonary valve.This device was being used for aortic stenosis.A comparative catheter was pulled and tested for rated burst pressure.This device was the same catalog number as the complaint catheter.The labeled rated burst pressure for this device is 2.0 atm.The comparative catheter was immersed in a body temperature bath and inflated until it failed.The catheter did not burst until 2.5 atm, which is above the labeled rbp of 2.0 atm.It is unknown what the complaint catheter burst at and it is also unknown if an inflation device with pressure gauge was used during the procedure as recommended in the instructions for use.
Event or Problem Description
As reported by the distributor bis "balloon ruptured during a case.In an email from the account (b)(6) 2017: balloon used for valvuloplasty, reported to have ruptured.While attempting to remove the catheter, the provider was unable to remove.Patient had to have catheter removed surgically.Balloon was being used for severe aortic stenosis.It is not documented whether or not an inflation device with pressure gauge was used.An 8fr standard sheath was used.It is unknown if there was anything unusual about the patient anatomy.Post procedure patient was transferred to the or for catheter removal, vital signs were within normal limits.A second balloon was not used to complete the procedure.It is not documented at what atm the balloon ruptured.".

• 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: 6865462
• Report Number: 1318694-2017-00026
• Device Sequence Number: 18860936
• Product Code: LIT
• UDI-Device Identifier: 04046964339332
• UDI-Public: 04046964339332
• 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,health profession
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/14/2017

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: Physician
• Device Expiration Date: 03/31/2021
• Device Model Number: 105
• Device Catalogue Number: PDC536
• Device Lot Number: TT-11860
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2017
• Initial Report FDA Received Date: 09/14/2017
• 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: 63 YR
• Patient Weight: 76