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

Model Number	SPL20020X
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The physician intended to use a sprinter legend balloon catheter to treat a lesion located in the mid obtuse marginal (om) which was reported to be moderately tortuous, moderately calcified with 90% stenosis.No damage noted to packaging, i.E.Shelf carton, hoop/tray and no issues noted when removing the device from the hoop/tray.The device was inspected and negative prep was performed with no issues identified.It was reported that the balloon would not deflate at the lesion site and deflation difficulties were experienced.The lesion was pre-dilated.It was reported that the physician was able to pull balloon back and remove as proximal artery was larger than the balloon.The device did not pass through a previously-deployed stent, no resistance encountered when advancing the device and no excessive force used during delivery.No patient injury reported.
Additional Manufacturer Narrative
Additional information: no difficulties were noted when removing the protective sheath/packaging stylette from the device.No difficulties were noted during the inflation of the device.The device was not moved or repositioned prior to the deflation difficulties.The balloon failed to deflate the physician used a 50/50 concentration of contrast/saline.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
User medwatch reference # mw5072811 was received.The patient presented with unstable angina device evaluation: balloon was returned partially inflated with contrast present inside.The balloon bond was stretched.Stretching was evident to the transition shaft proximal to the guidewire entry port.Kinking was visible along the transition shaft and hypotube, proximal to the guidewire entry port.A 0.015 inch mandrel could be loaded through the inner shaft and patency was verified.Upon pressurisation of the device, the device failed to inflate or deflate fully.No deformation was evident to the distal tip.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: 6735715
• Report Number: 9612164-2017-00927
• Device Sequence Number: 1411697
• Product Code: LOX
• UDI-Device Identifier: 00613994902092
• UDI-Public: 00613994902092
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup,Followup
• Report Date (Section B): 11/14/2017

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 Date: 01/05/2020
• Device Model Number: SPL20020X
• Device Catalogue Number: SPL20020X
• Device Lot Number: 212557226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Initial Date Received by Manufacturer: 06/27/2017
• Supplement Date Received by Manufacturer: 07/24/2017; 10/20/2017
• Initial Report FDA Received Date: 07/24/2017
• Supplement Report FDA Received Date: 08/23/2017; 11/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR