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

Catalog Number	SPR1515W
Medical Device Problem Codes	Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/21/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.

• Brand Name: SPRINTER OTW
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6960660
• Report Number: 9612164-2017-01483
• Device Sequence Number: 18974270
• Product Code: LOX
• UDI-Device Identifier: 00885074197029
• UDI-Public: 00885074197029
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P790017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2018
• Device Catalogue Number: SPR1515W
• Device Lot Number: 0008080694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 10/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR