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

Catalog Number	ADM05020013P
Medical Device Problem Codes	Leak/Splash (1354); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The in.Pact admiral was returned with no damage visible.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 and passed successfully through the device.Negative prep did detect the presence of a leak.On pressurization of the device a balloon leak was detected.Visual inspection confirmed the presence of a short longitudinal tear between the central markers.The tear was jagged and uneven indicating the balloon material may have been damaged prior to the leak occurring.The balloon could be partially inflated but was unable to maintain pressure.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician used a spider fx with a non-medtronic 7 fr sheath, a 0.014 guidewire and an in.Pact admiral dcb to treat a severely calcified lesion with cto (chronic total occlusion 100%) in the mid left popliteal artery.Lesion length and artery diameter were respectively 150 mm and 6 mm.The vessel presented moderate tortuosity.Ifu was followed.Negative prep was performed on the balloon.No leakage was observed.It was reported that difficulty was experienced when pulling the filter into the tip and inserting into the sheath during prep.The spider catheter was delivered over the 0.014 guidewire and then the guidewire was removed as per the ifu.When trying to advance the spider filter through the distal end of the catheter, it would not advance and seemed prolapsed within the delivery system.No detachment occurred.The entire system was then pulled and a new spider was delivered through an.035 non-medtronic wire (glidewire) and a 135 trailblazer.After the system was replaced, the physician progressed with the in.Pact admiral dcb.If u was followed and the device was prepped with no issued identified.An unknown inflation device was used and inflation difficulty was reported at 5 atm.No patient injury reported.These products were replaced with a 7.0 spider fx and a 5 x 200 in.Pact.

• 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: 8517425
• Report Number: 9612164-2019-01345
• Device Sequence Number: 19312806
• Product Code: ONU
• UDI-Device Identifier: 00643169975019
• UDI-Public: 00643169975019
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 04/16/2019

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: 07/03/2021
• Device Catalogue Number: ADM05020013P
• Device Lot Number: 0009220540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR