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

Model Number ADM04025013P

Device Problem Deflation Problem (1149)

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

Event Date 01/09/2023

Event Type  malfunction  

Manufacturer Narrative

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.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.

Event Description

Physician attempted to use an impact admiral drug coated balloon with a 6fr non-medtronic (cook) sheath and a 5mm spider fx guidewire/embolic protection device during treatment of a 300mm fibrous plaque lesion in patients right distal superficial femoral artery (sfa) & popliteal artery.Moderate vessel tortuosity and moderate vessel calcification are reported.Lesion exhibited cto (chronic total occlusion-100%) stenosis.Artery diameter reported as 4mm.A non-medtronic inflation device was used for balloon inflation.50/50 contrast mix inflation fluid was used.There was no damage noted to packaging.No issues were noted when removing the device from the hoop/tray.Ifu was followed and the device was prepped without issue.Resistance was noted during advancement of the device but no excessive force was used.The device was not passed through a previously deployed stent.It is reported that balloon deflation difficulties occurred on second inflation.No damage was noted to the balloon catheter.There were no issues noted during inflation.The balloon was eventually fully deflated for removal after approx.1-2 min through continuous negative pressure was used to complete procedure.No patient injury reported.

Manufacturer Narrative

Product analysis the device returned with deformation to the distal tip.The balloon folds were open.A tactile test detected flattening along the catheter from 71.6-72.7cm and 81.3-82.4cm proximal to the distal tip, and from 48.2-49.6cm and 46.5-47.5cm distal to the strain relief.There was a dent to the catheter at 36.1-36.2cm distal to the strain relief and there was a slight bend to the catheter at 8.8-10.6cm distal to the strain relief.A 0.035-inch guidewire was loaded via the distal tip with no resistance noted.Negative purge did not detect a leak on the device.The balloon was inflated to 5atm and was fully deflated 12 seconds after pulling a vacuum.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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 16245298
• MDR Text Key: 308149012
• Report Number: 9612164-2023-00392
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00643169975064
• UDI-Public: 00643169975064
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/13/2023

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 Model Number: ADM04025013P
• Device Catalogue Number: ADM04025013P
• Device Lot Number: 0011319305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/09/2023
• Initial Date FDA Received: 01/26/2023
• Supplement Dates Manufacturer Received: 02/21/2023
• Supplement Dates FDA Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2022
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 61 KG