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

Catalog Number	ADM05015013P
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2019
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, moderately tortuous plaque 80-90% stenotic lesion in the mid right superficial femoral artery(sfa).The artery diameter and lesion length were reported to be 5-6mm <(>&<)> 200mm, respectively.There was no damage noted to the packaging and there were no issues noted when removing the device from the tray/hoop.The device was prepped without issue.A 6fr non-medtronic sheath and a 0.014non-medronic hydro wire were used with no embolic protection.The device was inflated to 8atm with a non-medtronic inflation device and 60/40 hep saline/omnipaque solution used as inflation fluid.The device did pass through a previously deployed stent and resistance was encountered but no excessive force was used on advancing the device to the target lesion.The inpact admiral balloon was inflated but it did not hold pressure.The balloon was visualized with no abnormality under fluoroscopy.Pressure was continued for 40seconds.The device deflated and was removed without any difficulty.Upon removal it was inflated and a pinhole leak was observed.An additional 5x150 inpact admiral balloon from the same lot was used without incident to complete the procedure successfully.No patient injury was reported.
Additional Manufacturer Narrative
Cine review: still cine image capturing previously deployed stents in the sfa received.The reported pin-hole leak on the in.Pact admiral balloon cannot be confirmed from the still cine image provided.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: there were no abnormalities visualized upon prepping delivery catheter nor any resistance felt upon initial flush and no leaks or kinks observed.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: 8386176
• Report Number: 9612164-2019-00753
• Device Sequence Number: 277737
• Product Code: ONU
• UDI-Device Identifier: 00643169576339
• UDI-Public: 00643169576339
• 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,Followup
• Report Date (Section B): 07/12/2019

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: 09/19/2021
• Device Catalogue Number: ADM05015013P
• Device Lot Number: 0009337661
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 03/04/2019; 07/09/2019; 07/11/2019
• Initial Report FDA Received Date: 03/04/2019
• Supplement Report FDA Received Date: 03/20/2019; 07/11/2019; 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 48