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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
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MEDTRONIC IRELAND IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER Back to Search Results
Catalog Number ADM05012013P
Medical Device Problem Code Burst Container or Vessel (1074)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/01/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
An impact admiral drug-eluting balloon pta catheter, for a lower left angioplasty procedure, balloon burst occurred at nominal pressure (8atm).Physician removed the balloon catheter from the patient with no adverse effects.No patient injury was reported.
 
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Brand Name
IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER
Common Device Name
DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
MDR Report Key7127846
Report Number9612164-2017-02003
Device Sequence Number1423667
Product Code ONU
UDI-Device Identifier00643169383630
UDI-Public00643169383630
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P140010
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/18/2017
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
Operator of Device Health Professional
Device Expiration Date08/09/2018
Device Catalogue NumberADM05012013P
Device Lot Number0008152261
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/29/2017
Initial Report FDA Received Date12/18/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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