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

Model Number	NCSP2515X
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis summary: the device returned with a crack visible to the front face of luer.A hairline crack was evident to the back of the luer.The distal portion of the hairline crack curved towards the wing of the luer.The device failed negative prep.The balloon could not be inflated due to the crack on the luer.Blood was visible on the balloon.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 two nc sprinter rx ptca balloon catheters were intended to be used.There was no damage noted to the packaging of either device.There was no issues noted when removing the first nc sprinter device from the hoop.The devices were inspected with no issues noted.The luers of both nc sprinters were not inspected prior to attaching to the non medtronic inflation device.No difficulties were noted when attaching the luers of both nc sprinters directly to the inflation device.It was reported that both balloons were found to be leaking at the luer.The crack was not noted prior to attaching the luer of both nc sprinter devices to the inflation device.The leak was noticed when trying to inflate the balloon while in the patient.Neither balloon would inflate.The patient was reported to be alive with no injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: NC SPRINTER 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: 9828683
• Report Number: 9612164-2020-01158
• Device Sequence Number: 2421979
• Product Code: LOX
• UDI-Device Identifier: 00643169282315
• UDI-Public: 00643169282315
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 03/30/2020

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: 11/17/2021
• Device Model Number: NCSP2515X
• Device Catalogue Number: NCSP2515X
• Device Lot Number: 218955475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1