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

Catalog Number ADM06015013P

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information: a hawkone atherectomy device was used prior to the inflation of the in.Pact admiral.The type of balloon burst is unknown.The impact admiral was deflated and it was removed from the patient via a 6fr sheath.All fragments were removed.A pacific plus balloon was used after the burst of the impact admiral.There was no vessel damage.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Physician was using inpact admiral paclitaxel eluting balloon catheter during procedure to treat a mildly calcified lesion in the distal sfa.The device was inspected and prepped with no issues noted.It was reported that during balloon inflation, the balloon burst at 10 am.The lesion was not pre dilated.The device did not pass through a previously deployed stent and no resistance encountered.There was no patient injury reported.

Manufacturer Narrative

Device return 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 issues.Negative purge did not detect a presence of a leak on the device.The device was pressurised to 6 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: 9368941
• MDR Text Key: 170792146
• Report Number: 9612164-2019-04884
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00643169576353
• UDI-Public: 00643169576353
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2020

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: 05/27/2021
• Device Catalogue Number: ADM06015013P
• Device Lot Number: 0009157253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 11/25/2019
• Supplement Dates Manufacturer Received: 11/25/2019; 01/10/2020
• Supplement Dates FDA Received: 11/27/2019; 01/10/2020
• Date Device Manufactured: 05/28/2018
• 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
• Patient Weight: 77