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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND IN.PACT AV ACCESS; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

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MEDTRONIC IRELAND IN.PACT AV ACCESS; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER Back to Search Results
Catalog Number IAV05008008P
Device Problems Burst Container or Vessel (1074); Inflation Problem (1310)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/26/2024
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 av drug coated balloon (dcb) for treatment of a 6omm fibrous plaque lesion in the left upper arm shunt blood vessel.The vessel was 8mm in diameter with moderate tortuosity and calcification.A 7fr non medtronic sheath and a 0.045 150cm non medtronic guidewire was used.Embolic protection was not used.A syringe was used for inflation with contrast agent saline 5:5.The device was prepped as per the ifu with no issues identified.The device did not pass through a previously deployed stent.No resistance was encountered during delivery.It was reported the inpact av was inserted through the sheath to inflate the shunt vessel; when the deployment began according to the procedure, inflation difficulties were noted at 6 atm on cycle 1 and the balloon ruptured at 8atm.All fragments were retrieved.No patient injury was reported.
 
Manufacturer Narrative
Additional information: the balloon did not fragment, since the balloon part was not separated from the catheter, the catheter was removed as it was.No vessel damage was reported.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.
 
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Brand Name
IN.PACT AV ACCESS
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 Key19213372
MDR Text Key341565118
Report Number9612164-2024-02062
Device Sequence Number1
Product Code ONU
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P190008
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 05/22/2024
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 NumberIAV05008008P
Device Lot Number0012015810
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/26/2024
Initial Date FDA Received04/30/2024
Supplement Dates Manufacturer Received05/02/2024
Supplement Dates FDA Received05/22/2024
Date Device Manufactured10/27/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexMale
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