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

Catalog Number ADM04015013P

Device Problems Inflation Problem (1310); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2021

Event Type  malfunction  

Event Description

Physician was attempting to use the in.Pact admiral dcb during procedure to treat severely calcified lesion in the mid right superficial femoral artery (sfa).The vessel had moderate tortuosity and exhibited 90% stenosis.The artery diameter was 4-5mm and lesion length was 100mm.A non medtronic 6fr sheath and 0.014'' guidewire were used.The balloon was inflated with a non medtronic inflation device.Inflation fluid of 60/40 hep saline/omnipaque was used.There was no damage noted to packaging and no issues when removing the device from the hoop/tray.The device was prepped per the ifu with no issues.The device did not pass through a previously deployed stent and no resistance was encountered when advancing the device.It was reported that there was a burst/leak at 8atm during inflation.The sxc hawk was used for a total of 7 passes through lesion successfully with initial hesitation for initial three passes.In.Pact crossed without difficulty over the 0.014'' wire.Inflation to 8atm for 35 seconds, increased to 10 atm and the inflation devices appeared to not hold pressure.Scrub tech and physician acknowledged and so now leakage at attachment of stopcock nor on fluoro.Quickly deflated and re-inflated with same difficulty of not holding pressure.Deflated again and visualized them switching inflation device.The leak is believed to be through the balloon because upon the second deflation, blood was identified within the inflation device.There was no apparent leak at the hub or luer.The in.Pact device was removed fully intact leaving nothing behind.The procedure was completed with a second in.Pact device of same lot number.No patient injury.

Manufacturer Narrative

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

Manufacturer Narrative

Image review: image shows the superficial femoral artery (sfa) under fluoroscopy at the account.The vessel is moderately tortuous as reported by the account.There appears to be an area of restricted contrast flow in the distal section of the vessel in the image which is possibly the location of the reported lesion.The complaint device is not present in the image provided.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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 ANGIOPLAS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 13051056
• MDR Text Key: 286558003
• Report Number: 9612164-2021-04940
• Device Sequence Number: 1
• Product Code: ONU
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2022

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: 12/02/2023
• Device Catalogue Number: ADM04015013P
• Device Lot Number: 0010477139
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 12/21/2021
• Supplement Dates Manufacturer Received: 01/17/2022
• Supplement Dates FDA Received: 02/07/2022
• Date Device Manufactured: 12/02/2020
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 58 KG