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

Catalog Number	ADM06015013P
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2019
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
The physician intended to use an impact admiral to treat a fibrous lesion with 60% stenosis in a moderately tortuous mid superficial femoral artery (sfa).No embolic protection was used.The device was inflated using a non-medtronic inflation device.The device was prepped as per ifu with no issues reported.The device passed through a previously deployed stent, no resistance was encountered and excessive force was not used.It was reported that a pinhole balloon burst occurred during inflation to 8atm.The balloon was retrieved and removed from the patient.Another 6x150 impact admiral was used to complete the procedure with no complications reported.No patient injury was reported.
Additional Manufacturer Narrative
A non-medtronic 6fr 45cm sheath non-medtronic guidewire were used.Negative prep was performed without issues noted.The inpact admiral interacted with these devices.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: 8273769
• Report Number: 9612164-2019-00301
• Device Sequence Number: 11166980
• Product Code: ONU
• UDI-Device Identifier: 00643169576353
• UDI-Public: 00643169576353
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/10/2019

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: 05/27/2021
• Device Catalogue Number: ADM06015013P
• Device Lot Number: 0009157255
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/18/2019
• Supplement Date Received by Manufacturer: 01/24/2019; 01/24/2019
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 02/14/2019; 04/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1