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	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/02/2018
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-mdt sheath (6f), non-mdt.035 guidewire and non-mdt inflation device for the treatment of a moderately calcified lesion in the superficial femoral artery (sfa).Vessel described s being moderately tortuous.Lesion stenosis unknown.50/50 contrast/saline inflation fluid was used.It is reported the tech does not recall the device passing through a previously deployed stent, nor was there any excessive resistance encountered.Negative prep was not performed outside the body.When negative prep was attempted inside of the patient, a balloon burst, leak or rupture occured and blood return was noticed in the inflation device.The balloon did not inflate.A new in.Pact admiral device was used to complete the procedure.No patient injury reported.
Additional Manufacturer Narrative
Evaluation summary visual and tactile inspections were performed on the device: dry blood was found on the device and also inside the guidewire lumen and the inflating lumen.The folding on the balloon was still visible.The guide wire lumen was flushed and a 0,035¿¿ guide wire was successfully advanced through the device.Negative pressure was applied to the balloon: the purging procedure failed.Positive pressure was applied to the balloon, to identify the problem, but dry blood obstructed the inflating lumen.In order to detect the leak, the shaft was cut and a needle was inserted in the inflating lumen.Positive pressure was then applied to the balloon and a pinhole was clearly found on the balloon, at 3 cm from the tip.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: 7323449
• Report Number: 9612164-2018-00477
• Device Sequence Number: 110296
• Product Code: ONU
• UDI-Device Identifier: 00643169576339
• UDI-Public: 00643169576339
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 04/17/2018

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: 05/18/2019
• Device Catalogue Number: ADM05015013P
• Device Lot Number: 0008638024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Initial Date Received by Manufacturer: 02/08/2018
• Supplement Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 03/08/2018
• Supplement Report FDA Received Date: 04/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1