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

Catalog Number ADM04015013P

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Physician was using an in.Pact admiral paclitaxel eluting balloon catheter during procedure to treat a mildly calcified lesion in the left mid sfa with 50% stenosis.There was no damage noted to packaging and no issues noted when removing device from the hoop/tray.The device was inspected and prepped per ifu with no issues noted.It was reported that after pre dilation, the product crossed the lesion along with the guide wire, inflation was performed with the inflation device.At the stage that the pressure was applied to balloon up to 8 am, it was observed that there was leakage of contrast agent from the connector of hub and shaft.The pressure was also unstable.The procedure was continued without any action and was completed.Physician continued to apply pressure with indeflator until the end of the procedure.There was no patient injury reported.

Manufacturer Narrative

Additional information: the presence of leaks during prep could not be confirmed.No resistance was felt during prepping of the delivery catheter.The device was safely removed from the patient.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: a leakage of contrast agent from the connector of hub and shaft was reported.Analysis has confirmed this as a leak on the distal part of the hub product analysis: the device was returned to medtronic for evaluation.The device was decontaminated with cidex opa solution soak and tergazyme soak pending further device testing to support the final product analysis findings.The device returned with no damage visible to the catheter or balloon.The balloon folds were open.A tactile test did not detect any kinks or abnormalities along the length of the catheter.A 0.035 inch guidewire was loaded via the distal tip with no resistance noted.Negative purge did not detect a presence of a leak on the device.The device was pressurised to 4 atms and a leak was observed from the distal part of the hub.The leak was found in the distal bonding, between the shaft and the glue fillet.The glue fillet was lifted.It was possible to inflate the balloon; however, the device did not maintain pressure.If information is provided in the future, a supplemental report will be issued.

• Brand Name: IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9457242
• MDR Text Key: 187379892
• Report Number: 9612164-2019-05134
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2021
• Device Catalogue Number: ADM04015013P
• Device Lot Number: 0009454527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/12/2019
• Supplement Dates Manufacturer Received: 12/16/2019; 01/13/2020
• Supplement Dates FDA Received: 12/19/2019; 01/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1