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

Catalog Number	ADM04004013P
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: dry blood was found on the device and also inside the inflation lumen.The balloon was unfolded.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.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.
Event or Problem Description
Physician intended to use an in.Pact admiral for treatment of a lesion located in the patients right superficial femoral artery, ost ial/proximal to the profunda.The lesion was calcified but not tortuous.A non-medtronic inflation device, sheath and guidewire was used.The lesion was predilated using a non-medtronic balloon.Inflation fluid used was 50/50 contrast to hep saline.It is reported that a balloon burst occurred during the first inflation at 12 atms.The device was removed from the patient without fragmentation/further issue.Another in.Pact admiral balloon along with the previously used non-medtronic balloon were used to complete the procedure.No patient injury was 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: 7517595
• Report Number: 9612164-2018-01095
• Device Sequence Number: 1385188
• Product Code: ONU
• UDI-Device Identifier: 00643169383500
• UDI-Public: 00643169383500
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 05/16/2018

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: 09/17/2020
• Device Catalogue Number: ADM04004013P
• Device Lot Number: 0008799979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 113