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

Catalog Number ADM05015013P

Device Problem Leak/Splash (1354)

Patient Problems Patient Problem/Medical Problem (2688); Vascular Dissection (3160)

Event Date 06/04/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the physician was using an inpact admiral dcb balloon to treat a moderately calcified, slightly tortuous, fibrous lesion in the mid right superficial femoral artery(sfa).The artery diameter and lesion length were reported to be 5mm and 200mm, respectively.There was no issues noted when removing the device from the package or the tray/hoop.The device was prepped without issue.A 6fr non-medtronic sheath and a 0.014 non-medtronic were used with no embolic protection.The device was inflated with a syringe using saline dilution of the contrast as inflation fluid.The device did not pass through a previously deployed stent, no resistance was encountered nor excessive force used on advancing the device to the target lesion.On applying the pressure, the balloon was observed to be leaking at the catheter hub.The pressure was increased to 8atm to keep the balloon inflated to deliver the treatment.After 120seconds, the balloon was withdrawn and a dissection was observed under angiography.A stent was used to treat the dissection.

Manufacturer Narrative

No resistance was felt during prep.Balloon removed from patient without issue.A non-medtronic stent was used to treat the dissection.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Device evaluation 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 0.035inch 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 8 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: 8677983
• MDR Text Key: 147298939
• Report Number: 9612164-2019-02231
• 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: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2022
• Device Catalogue Number: ADM05015013P
• Device Lot Number: 0009530386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2019
• Initial Date FDA Received: 06/07/2019
• Supplement Dates Manufacturer Received: 06/24/2019; 07/30/2019
• Supplement Dates FDA Received: 07/03/2019; 08/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2019
• 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
• Patient Outcome(s): Required Intervention