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

Model Number	SPL25020X
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2018
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 balloon catheter was attempted to be used.There was no damage noted to the device packaging.The device was inspected with no issues.Negative prep was performed with no issues.It is reported that the balloon failed to deflate at the lesion site.No patient injury is reported.
Additional Manufacturer Narrative
Additional info: the lesion was in the mid lad.There was moderate tortuosity, low degree of calcification, and 80% lesion stenosis.There was no damage noted to the device packaging.No issues were noted when removing the device from the hoop/tray.No difficulties were noted when removing the protective sheath from the device.No difficulties were noted when removing the packaging stylette from the device.The lesion was not pre-dilated.The device did not pass through a previously-deployed stent.No resistance was encountered when advancing the device.Excessive force was not used during delivery.No difficulties noted during inflation of the device.The device was not moved or repositioned prior to the deflation difficulties.It is reported that the balloon failed to deflate at the lesion site after first inflation.The balloon eventually deflated slowly.60% contrast/40% saline was used.No intervention was used to remove the device from the patient.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: device decontaminated with cidex-opa.The balloon returned deflated with crystallised residue present inside the balloon and the inflation lumen.The device was placed in the waterbath to disperse the residue in the balloon and inflation lumen in order to aid inflation.The balloon inflated at nominal pressure of 8atm with no issues noted.Upon visual inspection the proximal balloon bond appeared stretched.The balloon deflated in 6s with no issues noted.Deformation was evident to the distal tip.The inner lumen patency was verified with a 0.015 inch mandrel.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 7713295
• Report Number: 9612164-2018-01836
• Device Sequence Number: 1452125
• Product Code: LOX
• UDI-Device Identifier: 00613994902566
• UDI-Public: 00613994902566
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Followup
• Report Date (Section B): 11/02/2018

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: 08/22/2020
• Device Model Number: SPL25020X
• Device Catalogue Number: SPL25020X
• Device Lot Number: 213888199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Initial Date Received by Manufacturer: 06/29/2018
• Supplement Date Received by Manufacturer: 07/24/2018; 08/08/2018; 10/05/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 08/20/2018; 10/03/2018; 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 104