MAUDE Adverse Event Report: MEDTRONIC, INC. IN.PACT ADMIRAL; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Model Number	ADM06004013P
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Incident description: upon doing percutaneous transluminal angioplasty (pta) on patient's right superficial femoral artery (sfa), the drug-eluting balloon appeared to be losing atmospheres of pressure due to possible leakage of balloon.The dwell time for this balloon is 3 minutes at 8 atms, but after 2 minutes, all solution in inflation device was gone, so we had to disconnect inflation device, refill w/saline contrast mixture and re-inflate.Then i noticed the device was leaking out of the proximal end of balloon catheter at the junction between the clear y-connector and the blue catheter shaft on the proximal end.No harm was done to patient.No other balloons or devices used.Results of procedure were good.Procedural note: procedure in detail: we engaged the right common iliac artery with a diagnostic internal mammary artery (ima) catheter, advanced a glidewire stiff exchange length into the right superficial femoral artery.We then exchanged our short 6-french sheath with a 6-french 45 cm cook sheath.We traversed the lesion.We predilated the sheath with a 5 mm balloon, and because the lesion was quite focal and responded pretty nicely to the balloon angioplasty, we proceeded to use the drug-coated balloon, admiral, 6x4.We did an 18 atmosphere dilatation for a total of 3 minutes.Follow-up angiographic results were excellent with, angiographically, no significant residual stenosis identified.There is no dissection.There is brisk flow.Sheathogram performed had demonstrated good access and therefore a proglide device was deployed with good hemostasis.

• Brand Name: IN.PACT ADMIRAL
• Common Device Name: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic pkwy; minneapolis MN 55432
• MDR Report Key: 10275405
• Report Number: 10275405
• Device Sequence Number: 2603411
• Product Code: ONU
• UDI-Device Identifier: 00643169383258
• UDI-Public: (01)00643169383258(17)210724(10)0009252736
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/15/2020
• Report Date (Section F): 07/14/2020

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
• Operator of Device: Health Professional
• Device Model Number: ADM06004013P
• Device Catalogue Number: ADM06004013P
• Device Lot Number: 0009252736
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/15/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 67
• Date Report Sent to FDA: 07/14/2020