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

Catalog Number ADM04015008P

Device Problems Inflation Problem (1310); Contamination /Decontamination Problem (2895)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The physician was using an inpact admiral to treat a lesion in the superficial femoral artery (sfa).A non medtronic guidewire and a non medtronic sheath were used in the procedure.A non medtronic balloon catheter (4x150cm-150) was used to complete pre-dilation.When removing the stylet from the balloon portion of the device, a wire-like metal piece protruded about 0.5 mm from the tip portion of the balloon.The tip portion was unable to be caught, and the 0.035 wire was inserted from the guide wire port and the metal part was extruded from the tip portion and removed.The removed metal was a thin rod and about 30 cm in length.The diameter was narrow than the stylet and it was unlikely that the stylet of the section was broken.The device was prepped and negative pressure was applied there were no other abnormalities observed and the product was used for the procedure.However, the balloon did not inflate as normal during balloon inflation and the pressure decreased halfway.Although the physician suspected that the balloon was broken, i t was not confirmed and the procedure was continued.When the pressure decreased, it was possible to inflate by turning the inflation device.The balloon inflated and the procedure was completed.There was no difficulty removing the device.Post dilation was not completed.No patient injury was reported.

Manufacturer Narrative

Luer leak device evaluation the balloon folds were open.The strain relief was detached from the nose of the luer.It was possible to insert 0,035 guidewire without any issue.Negative purge did detect a presence of a leak on the device.In order to verify the point of leak, an attempt was made to inflate the balloon and the leak was found on the distal part of the hub.The leak was noted at 2 atm.The leak was found in the distal bonding, between the shaft and the glue fillet.The glue fillet was slightly lifted.It was not possible to inflate the balloon.A kink in the balloon material was observed 14 mm from the distal tip.An unidentified wire 28cm in length was returned with the device.The od of the unidentified wire was 0.037mm.The unidentified wire had a slight curve.Both ends of the unidentified wire were deburred, indicating that this was not a section of wire that had detached from the device technical analysis confirmed that an unidentified wire returned along with the device.It is most likely that the unidentified wire was introduced post release of the device from the manufacturing facility.No manufacturing related or potential manufacturing related root cause was identified.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: 8394646
• MDR Text Key: 137957052
• Report Number: 9612164-2019-00791
• 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
• Report Date: 08/30/2019

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: 09/10/2021
• Device Catalogue Number: ADM04015008P
• Device Lot Number: 0009316409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2019
• Initial Date FDA Received: 03/06/2019
• Supplement Dates Manufacturer Received: 08/29/2019
• Supplement Dates FDA Received: 08/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1