MAUDE Adverse Event Report: MEDTRONIC MEXICO SPRINTER LEGEND RX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Catalog Number	SPL20012X
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2019
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
A sprinter legend rx ptca balloon catheter was used to treat a moderately tortuosity and calcified lesion exhibiting 90% stenosis in the proximal ramus.The device was inspected with no issues noted.Negative prep was performed.The lesion was not pre dilated.The device did not pass through a previously deployed stent.Resistance was encountered.Excessive force was not used during delivery.It was reported that there was calcium present proximal to the target lesion that the balloon got hung up on.The balloon had to be manipulated to pass the calcified segment.It was reported that the balloon never inflated and ruptured immediately.Contrast was visible distal to the distal markerband.The procedure was completed using another 2.0x12 mm sprinter balloon.The patient was reported as alive with no injury.
Additional Manufacturer Narrative
Device evaluation summary: the balloon folds were intact.Blood was visible in the balloon and inflation lumen.The balloon failed negative prep.On pressurisation of the device, liquid was observed exiting the balloon distal cone.The balloon failed to maintain pressure.Upon visual inspection of the device, there was a radial tear on the balloon distal cone material.The balloon material was smooth and straight.There was no other damage evident to the remainder of the device.Image review: images show multiple lesions, in the lad and the ramus vessel.Images show pre dilation of the lesion in the ramus vessel.Further pre dilations in the proximal vessel are performed.Images show the vessel following pre dilation.A stent is delivered to the lesion and deployed.A second stent is delivered to the left main and deployed.Post dilation of the stent is performed.An image shows the treated vessels and the procedure is completed.There were no images showing the reported difficulty delivering the balloon or the reported balloon burst.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The sprinter legend rx ptca balloon catheter was intended to be used to pre-dilate the lesion.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPRINTER LEGEND RX
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 8783942
• Report Number: 9612164-2019-02826
• Device Sequence Number: 2338757
• Product Code: LOX
• UDI-Device Identifier: 00613994902153
• UDI-Public: 00613994902153
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2019

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 Date: 09/11/2020
• Device Catalogue Number: SPL20012X
• Device Lot Number: 214010760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 07/19/2019; 09/10/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 08/13/2019; 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 74