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

Catalog Number	ADM05015013P
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the device was returned for evaluation.A visual and a tactile inspection were performed.The device had dried blood on it.The balloon was unfolded.It was not possible to advance the 0.035¿ guidewire due to the presence of the dried blood inside the lumen.Negative pressure was applied; the purging test failed.An attempt to inflate the balloon was conducted but a leak was detected on the balloon: a small cut was found on the distal cone of the balloon.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician intended to use the in.Pact admiral to treat a lesion in the mid popliteal artery with no tortuosity, calcification and 60% stenosis as per ifu.A non-medtronic inflation device along with a 6f size sheath <(>&<)> a non-medtronic guidewire were used.Negative prep was performed with no abnormalities noted.The lesion was prepped with atherectomy.No resistance or excessive force was used, the device did not pass through a previously deployed stent.It was reported during the procedure the physician encountered inflation difficulties at 8atm.The balloon would not expand to it proper size.No leakage of contrast was noted on the device.Another device was used to complete the procedure.No patient injury reported.

• 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: 8018414
• Report Number: 9612164-2018-02983
• Device Sequence Number: 13791222
• Product Code: ONU
• UDI-Device Identifier: 00643169576339
• UDI-Public: 00643169576339
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 10/30/2018

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: 03/04/2021
• Device Catalogue Number: ADM05015013P
• Device Lot Number: 0009020554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 10/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR