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	08/16/2018
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
It was reported that the physician had used an in.Pact admiral device on a plaque lesion in the patients mid right superficial femoral artery but it had burst.The physician then took a second in.Pact admiral device with a 7f sheath and a 6mm spider fx embolic protection device for treatment of the lesion.Slight calcification and tortuosity were reported.The ifu was followed and the device was prepped, including drawing a negative pressure, without issue.An unknown inflation device was used.It was reported that pinhole balloon burst occurred on the device at an inflation pressure of 10atm on the first inflation of the device.The procedure was completed using plain old balloon angioplasty (poba).No patient injury was reported.
Additional Manufacturer Narrative
Evaluation summary: the device was returned for evaluation.Visual and tactile inspections were performed on the device.The balloon was unfolded and dirty with blood.It was not possible to load the 0,035¿¿ guidewire due to the hardened blood inside the lumen.Negative pressure was applied to the balloon and the purging procedure failed.An attempt to inflate the balloon was made but a pinhole was detected and it was not possible to maintain 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: 7881197
• Report Number: 9612164-2018-02414
• Device Sequence Number: 2366259
• Product Code: ONU
• UDI-Device Identifier: 00643169383258
• UDI-Public: 00643169383258
• 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
• Report Date (Section B): 11/13/2018

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: 03/27/2021
• Device Catalogue Number: ADM06004013P
• Device Lot Number: 0009050030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR