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

Catalog Number SBI05015013P

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported the physician used an in.Pact admiral paclitaxel-eluting pta balloon for the treatment of a minimally calcified lesion in the left superficial femoral artery of the patient.Vessel exhibited no tortuosity.It is unknown if ifu was followed.A 6 fr non-mdt guidewire was placed in the patient from the right main femoral.A 6mmx250mm non-mdt normal balloon was passed from this sheath and the lesion was pre-dilated.The physician then intended to use the 6mmx120mm in.Pact admiral balloon.This balloon could not be advanced through the sheath, and resulted in deformation of the balloon.Therefore, this balloon was pulled back.After the issue with first in.Pact admiral balloon, a second 5mmx150mm in.Pact admiral balloon was used.Post-treatment of the lesion site, the physician experienced difficulties when trying to remove the device.It was reported that the balloon was completely deflated, but it is unknown if negative pressure was held prior to and during retraction.The balloon could not be pulled back into the sheath and it was stuck because it did not enter the sheath.The device was not retracted at an acute angle relative to the mouth of the sheath.The balloon was then removed by pulling it together with the sheath and the procedure was completed with this way.No patient injury was reported as a result of this event.

Manufacturer Narrative

Evaluation summary: visual and tactile inspections were performed on the device: traces of blood were found on the device and traces of radio opaque solution into inflation line.A kink was detected on the shaft at 36 cm from the tip.The balloon was found inflated, with a slightly kinked part.The guide wire lumen was flushed and an a 0,035¿¿ guide wire was successfully advanced.The purging procedure was performed with no issues.The device was inserted in a 6f cordis introducer sheath.No resistance was felt both during insertion and extraction.No further issues found.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: 7243106
• MDR Text Key: 99092113
• Report Number: 9612164-2018-00200
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2020
• Device Catalogue Number: SBI05015013P
• Device Lot Number: 0008682091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2017
• 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 Age: 54 YR