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

Model Number	SPL20012X
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis summary: the device returned with a crack evident to the front side of the luer, the distal portion of the crack curved towards the wing of the luer.A hairline crack was also evident to the back face of the luer.The device failed negative prep.It was not possible to inflate the balloon due to the crack on the luer.Contrast was visible in both the inflation lumen and balloon.The balloon folds returned expanded.No other damage was evident to the remainder of the device.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During a procedure a sprinter legend rx ptca balloon catheter was intended to be used.There was no damage noted to the packaging or any issues noted when removing the device from the hoop.The device was inspected with no issues noted.Negative prep was performed without issues.The lesion was pre-dilated.The device was not kinked and restraightened during use.It was reported that the luer of the device cracked during preparation of the device in vitro.The physician stated that when the inflation device was attached to the balloon the attachment was uneven.It was indicated that the luer cracked upon balloon inflation.The patient was reported to be alive with no injury.

• 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: 9883438
• Report Number: 9612164-2020-01363
• Device Sequence Number: 492565
• 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: K103095
• 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): 03/26/2020

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: 10/30/2022
• Device Model Number: SPL20012X
• Device Catalogue Number: SPL20012X
• Device Lot Number: 218809815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1