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

Model Number	ADM06025013P
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: the balloon was safely removed from the patient.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation: the device returned with no damage visible to the catheter, the balloon folds were open.A tactile test did not detect any kinks or abnormalities along the length of the catheter.A 0.035 inch guidewire was loaded via the distal tip with no resistance noted.Negative purge detected the presence of a leak on the device.The device was pressurised to 4 atms and a pin-hole leak was observed from the mid to distal part of the balloon.Indentation/scratch marks were visible along the balloon material.It was possible to inflate the balloon; however, the device did not maintain pressure.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.
Event or Problem Description
The physician attempted to use an in.Pact admiral dcb device to treat a lesion in the mid superficial femoral artery.There was no damage noted to the packaging.The device was inspected with no issues noted.Negative prep was performed with no issues.The lesion was pre-dilated.The device was passed through a previously deployed stent.There was no resistance encountered when advancing the device and no excessive force was used during delivery.It was reported that during balloon inflation, inflation difficulties occurred.The balloon never held pressure at 8 atm.Balloon pin-hole was identified when device was tested in vitro.There was not balloon burst but a balloon leak.There was no injury to the patient.

• 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: 9591431
• Report Number: 9612164-2020-00248
• Device Sequence Number: 534907
• Product Code: ONU
• UDI-Device Identifier: 00643169975088
• UDI-Public: 00643169975088
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 02/25/2020

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: 12/10/2021
• Device Model Number: ADM06025013P
• Device Catalogue Number: ADM06025013P
• Device Lot Number: 0009468338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 01/15/2020; 02/24/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 01/17/2020; 02/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1