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

Catalog Number	ADM07004013P
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2018
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
The physician was attempting to use a in.Pact admiral with a non-mdt (7 destination terumo) and a non-mdt (0.035 glidewire) to treat a 375mm moderately calcified plaque lesion with cto (chronic total occlusion 100%) in the right proximal mid distal superficial femoral artery (6-7mm diameter).Little tortuosity was reported.The device was prepped as per the ifu with no issues identified.Negative prep was performed.No embolic protection was used.The balloon was inflated using a non-mdt (boston scientific) inflation device.Saline and contrast fluid were used.No resistance was encountered when advancing the device and no excessive force was used.It was reported by the technician that during the first balloon inflation to 10atm the balloon was leaking where the shaft attaches to the hub.The physician expressed concern the balloon was not holding pressure.The balloon was removed as one piece.No visual damage could be seen.The procedure was completed using another 7x40 drug coated 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 was returned for evaluation.A visual and tactile inspection was performed on the device.The balloon was unfolded and dirty with blood.A 0,035¿¿ guiewire was easily loaded through the guidewire lumen.The purging procedure was performed, but a leak was revealed, as the bubble flow under negative pressure did not stop.The rubber was removed from its original position.In order to verify the point of leak, an attempt was done to inflate the balloon and the leak was found on the distal part of the hub.The leak was found in the distal bonding, between the shaft and the glue collar.It was possible to inflate the balloon but the device did not hold the pressure.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: 7863528
• Report Number: 9612164-2018-02345
• Device Sequence Number: 11221466
• Product Code: ONU
• UDI-Device Identifier: 00643169383340
• UDI-Public: 00643169383340
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/04/2021
• Device Catalogue Number: ADM07004013P
• Device Lot Number: 0009020552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2018
• Supplement Date Received by Manufacturer: 08/14/2018; 09/18/2018
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 09/11/2018; 10/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 111