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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND SPRINTER OTW CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

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MEDTRONIC IRELAND SPRINTER OTW CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Catalog Number SPR1515W
Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Patient Problems Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)
Event Date 09/21/2017
Event Type  Injury  
Manufacturer Narrative
Evaluation summary: device was returned with blood residue present throughout. Device was placed in water bath overnight to disperse residue. Upon removed from the water-bath a clear detachment was observed. Detachment site was located at the balloon, on the balloons working length. Detachment site was 3cm proximal to the distal tip. The distal end of the detachment site was not returned for analysis. The balloon material was jagged and uneven on proximal detachment site. Deformation was visible to the distal tip.
 
Event Description
It was intended to use a sprinter otw balloon catheter to treat a severely tortuous, severely calcified distal lesion exhibiting 95% stenosis in a peripheral artery (below the knee near the foot). There was no damage noted to packaging or issues removing the device from the hoop/tray. No stylet removal difficulties. The device was inspected and prepped with no issues noted. The lesion was not pre-dilated. The device did not pass through a previously deployed stent. Resistance was encountered when advancing the device however excessive force was not used. The device was not kinked and re-straightened during use. It is reported that upon inflation, the balloon burst at 10 atm. There was a sudden drop in pressure from inflation device. The balloon was not repositioned before burst. The balloon then separated from the shaft with the single marker intact and when the physician removed the system from the patient the detached portion remained in the very distal tibial artery. An attempt was made to snare with a loop snare however the snare could not get all the way down to the foot. A surgical consult decided that it was not an option to cut down and remove the balloon. The detached portion of the device remains in the patient.
 
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Brand NameSPRINTER OTW
Type of DeviceCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key6960660
MDR Text Key89675870
Report Number9612164-2017-01483
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P790017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 10/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/01/2018
Device Catalogue NumberSPR1515W
Device Lot Number0008080694
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/11/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/19/2017 Patient Sequence Number: 1
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