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 Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician intended to use an inpact admiral for patient treatment on the superficial femoral artery (sfa).The mid lesion had little degree of tortuosity.A non-medtronic 6fr 63cm sheath and two non-medtronic guidewires were used.There was no issues noted with the product being removed from the hoop/tray.Ifu was followed.The device did not pass through a previously-deployed stent and no resistance was used nor was excessive force used.The lesion was pre-dilated.It was reported that the procedure was completed with this device; however, when the device was removed from the patient, there was a fiber-like object adhered to the balloon.There was no patient injury reported.

Manufacturer Narrative

Additional information: there was no complications or issues with the device during the procedure.The device was inspected prior to use.There was no signs of damage or tampering noted to the packaging.The patient has not been given any additional treatment.The fiber-like material was taken out of the patient.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the fiber-like material from the balloon surface was removed and put in a container.The device was safely removed from the patient.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image review: the in.Pact admiral device did not return for analysis, however, the ¿foreign material¿ sample was provided for analysis.The sample was analysed via fourier-transform infrared spectroscopy (ftir) testing in an attempt to identify the sample.While material produced a similar spectrum to paclitaxel drug, the exact identity of the foreign material could not be determined via ftir.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: 9784948
• MDR Text Key: 190326152
• Report Number: 9612164-2020-00993
• 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,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2022
• Device Catalogue Number: ADM06015013P
• Device Lot Number: 0009603647
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2020
• Date Device Manufactured: 02/22/2019
• 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