• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND IN.PACT 018 PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOO; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC IRELAND IN.PACT 018 PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOO; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER Back to Search Results
Catalog Number IPU07008013P
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/24/2024
Event Type  malfunction  
Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
Event Description
A physician was attempting to use an inpact 018 drug coated balloon with a 6fr non-medtronic sheath and a 235cm 0.014 non-medtronic guidewire during procedure to treat a 60mm plaque lesion in the patients left proximal superficial femoral artery.No vessel tortuosity and moderate vessel calcification were reported.Lesion exhibited cto (chronic total occlusion-100%) stenosis.Artery diameter is reported as 7mm.There were no anatomical abnormalities reported.There were no issues noted when removing the device from the hoop/tray.The device was prepped per the ifu (instruction for use) with no issues noted.Embolic protection was not used.A non-medtronic inflation device was used for balloon inflation.A balloon twist was reported.It was not possible to apply drug to one area due to the twisting of the balloon.A rewrap tool was not used.The device did not pass through a previously deployed stent.No resistance was encountered when advancing device.An additional inpact 018 was used to complete procedure.No patient injury reported.
 
Manufacturer Narrative
Additional information: inflation fluid was used.A noted dog-bone/twist was visible within the balloon in the vessel.Even if the pressure was increased to the recommended pressure (8atm), the twisting did not release, and even though the pressure applied to rbp, it could not be released.The device was safely removed from the patient.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
IN.PACT 018 PACLITAXEL-COATED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOO
Type of Device
DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
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 Key19200462
MDR Text Key341247859
Report Number9612164-2024-02030
Device Sequence Number1
Product Code ONU
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P140010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/27/2024
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 Catalogue NumberIPU07008013P
Device Lot Number0012070419
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/25/2024
Initial Date FDA Received04/29/2024
Supplement Dates Manufacturer Received05/04/2024
Supplement Dates FDA Received05/27/2024
Date Device Manufactured12/07/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-