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

Catalog Number	ADM06008013P
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2018
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
Physician intended to use an in.Pact admiral device with a non-medtronic 0.014 wire for treatment of a calcified lesion in the patients popliteal artery.Moderate tortuosity and calcification are reported.Lesion exhibited 70% stenosis.Oribtal atherectomy was carried out prior to treatment with the in.Pact admiral device.No embolic protection was used.The device was prepped as per ifu without issue.It is reported the device passed through a previously deployed stent.An inflation device was used for balloon inflation.It is reported a balloon rupture occurred at an unknown inflation pressure.No balloon fragments were observed when ruptured.The rupture did not cause any injury to the patient.The device was replaced with another in.Pact admiral to complete the procedure.No patient injury reported.
Additional Manufacturer Narrative
Evaluation summary: the device was returned for analysis.A visual and tactile inspection was performed without any issue identified.A 0.035¿ guidewire was successfully advanced through the device.Negative pressure was applied but the purging test failed.An attempt to inflate the balloon was unsuccessful as a leak was detected.A pinhole was found on the balloon, near the distal marker.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: 7783978
• Report Number: 9612164-2018-02048
• Device Sequence Number: 2076685
• Product Code: ONU
• UDI-Device Identifier: 00643169383272
• UDI-Public: 00643169383272
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 10/04/2018

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: 01/25/2019
• Device Catalogue Number: ADM06008013P
• Device Lot Number: 0008469668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 08/15/2018
• Supplement Report FDA Received Date: 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 74