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

Catalog Number	ADM04015013P
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/15/2018
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
Physician was attempting to use a in.Pact admiral a 5fr sheath & a 0.035 non-mdt guidewire to treat an 120mm severely calcified lesion with 80% stenosis in the right proximal superficial femoral artery of 4mm in diameter.The device was prepped as per ifu with no issues identified.Resistance was encountered during advancement of the device but no excessive force was used.The device was inflated using a non-mdt inflation device.It was reported that during the first inflation to 8atm balloon inflation difficulties were encountered and a balloon leak was observed.The balloon appeared intact upon removal, blood returned into the inflation device during deflation of the balloon.The procedure was completed using an evercross balloon.No patient injury was reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: the device has been returned for evaluation.A visual and tactile analysis was performed: dry blood was found on the balloon and on the entire catheter.No further issue were detected.During the technical analysis, the guidewire lumen was flushed and a 0.035¿ guidewire was successfully advanced through the device.The purging test failed.An attempt to inflate the balloon was conducted however a balloon pinhole was found in the middle of the balloon length.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: 7863603
• Report Number: 9612164-2018-02351
• Device Sequence Number: 1566976
• Product Code: ONU
• UDI-Device Identifier: 00643169576315
• UDI-Public: 00643169576315
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 10/11/2018

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: 01/07/2021
• Device Catalogue Number: ADM04015013P
• Device Lot Number: 0008944152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 08/15/2018; 09/13/2018
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 09/11/2018; 10/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR