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

Model Number	ADM06006013P
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was attempting to use an in.Pact admiral paclita drug eluting balloon to treat a severely calcified proximal sfa lesion.The lesion was 100 mm in length with 70% stenosis.The artery diameter is 6 mm with no tortuosity.No abnormalities were reported in relation to the patient¿s anatomy.The device was removed from its packaging and inspected with no issues noted.The device was prepped as per the ifu.No embolic protection was used.The in.Pact admiral paclita drug eluting balloon was passed through a previously deployed stent and no resistance was encountered during advancement.No excessive force was used.A non-medtronic inflation device was used.The balloon burst at 8 atms on the first inflation.The physician completed the procedure using a fortrex balloon and placing a covered stent.No patient injury was reported.
Additional Manufacturer Narrative
Evaluation summary: the catheter returned with its original pouch and box.During the technical investigation, the device was visually inspected.The balloon catheter shows traced of blood in the balloon and along the shaft.The device had no damage: no shaft kinks or deformations, no tip damage.A 30 mm longitudinal cut was detected on the proximal side of the balloon.The guidewire used was 0.035" and a 6 fr competitor sheath was also utilised.The lesion was not pre-dilated.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: 6863175
• Report Number: 9612164-2017-01253
• Device Sequence Number: 13628016
• Product Code: ONU
• UDI-Device Identifier: 00643169383265
• UDI-Public: 00643169383265
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 12/11/2017

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: 09/30/2018
• Device Model Number: ADM06006013P
• Device Catalogue Number: ADM06006013P
• Device Lot Number: 0008240650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Initial Date Received by Manufacturer: 08/15/2017
• Supplement Date Received by Manufacturer: 11/21/2017
• Initial Report FDA Received Date: 09/13/2017
• Supplement Report FDA Received Date: 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 92