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 Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/14/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The physician intended to use an in.Pact admiral paclitaxel-eluting pta balloon catheter during procedure for treatment of the distal right sfa and popliteal artery.The calcified lesion exhibited little tortuosity and severe calcification with chronic total occlusion 100%.Artery diameter was 6mm with a lesion length of 200mm.Long cto using popliteal approach was reported.A non medtronic sheath and 0.018 wire were also used during procedure.Embolic protection was not used.A non medtronic inflation device was used during procedure with contrast/saline mix.There was no damage noted to the packaging.There was no issue noted when removing the device from the hoop/tray.The device was prepped per ifu with no issues identified.It is reported that the device or component detached, cracked, or fractured upon removal through the sheath.The break/fracture occurred at catheter.Removal difficulties were reported.There was difficulty removing the balloon following balloon inflation.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was used during withdrawal.Procedure was completed using brachial approach; access was obtained prior to event.There were no patient symptoms or complications associated with this event.

• 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: 6705113
• Report Number: 9612164-2017-00870
• Device Sequence Number: 13845685
• Product Code: ONU
• UDI-Device Identifier: 00643169576353
• UDI-Public: 00643169576353
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Report Date (Section B): 06/14/2017

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: 10/07/2018
• Device Catalogue Number: ADM06015013P
• Device Lot Number: 0008251784
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2017
• Initial Report FDA Received Date: 07/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 46