MAUDE Adverse Event Report: MEDTRONIC IRELAND IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Catalog Number	ADM06008013P
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician intended to use an inpact admiral balloon to treat a moderately calcified non tortuous plaque lesion in the left proximal superficial femoral artery(sfa).The device was prepped as per ifu with no issue identified.It was reported that upon inflation, the balloon did not hold pressure.Thus, it was reported that the lesion was not treated for the required 3 minutes.A new device was used to complete the procedure.No patient injury was reported.
Additional Manufacturer Narrative
Additional information: embolic protection was not used.A 6fx45cm non-medtronic sheath was used.No resistance was felt during prepping of the delivery catheter and no leaks were observed from ports/balloon during prep.The balloon was inflated using a non-medtronic inflation device.Negative prep was performed.The device was safely removed from the patient.A pinhole leak was observed on the balloon.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER
• Common Device Name: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8448174
• Report Number: 9612164-2019-01022
• Device Sequence Number: 19577703
• Product Code: ONU
• UDI-Device Identifier: 00643169383272
• UDI-Public: 00643169383272
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P140010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2019

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 Expiration Date: 10/21/2021
• Device Catalogue Number: ADM06008013P
• Device Lot Number: 0009384833
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 04/09/2019; 05/13/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 05/03/2019; 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR