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

Catalog Number	ADM06004013P
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2017
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 one in.Pact admiral paclitaxel-eluting pta balloon to post-dilate a moderately tortuous and moderately calcified lesion located in the mid left common iliac artery, sfa and popliteal artery area.Negative prep was performed with no bubbles noted.Non-mdt sheaths and guidewires were used, and a spider embolic protection device was used.A non-mdt inflation device was also used.The device was removed from its packaging and inspected with no issues noted.The device was prepped per the ifu.The device did not pass through a previously deployed stent.No resistance was encountered when advancing the device and no excessive force was used.It was reported that when the physician gradually inflated the device to 4 atm pressure for the first time, the balloon ruptured, and a rapid pressure drop was noted on the inflation device.The physician removed the device from the patient, and used a new device to complete the procedure.No patient injury was reported.
Additional Manufacturer Narrative
Additional information: the lesion was 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: 7051874
• Report Number: 9612164-2017-01645
• Device Sequence Number: 94127
• Product Code: ONU
• UDI-Device Identifier: 00643169383258
• UDI-Public: 00643169383258
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 12/18/2017

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: 06/27/2019
• Device Catalogue Number: ADM06004013P
• Device Lot Number: 0008689619
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2017
• Supplement Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 11/22/2017
• Supplement Report FDA Received Date: 12/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1