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

Model Number	SPL12515X
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2020
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
During a procedure, an attempt was made to use one sprinter legend rx ptca balloon catheter to treat a lesion located in the right coronary artery.There was no damage noted to the packaging and there was no issues noted when removing the device from the hoop.The device was inspected with no issues noted.An attempt was made to connect the luer of the sprinter legend to an inflation device with no issues noted.The luer of the sprinter legend was not inspected prior to attaching to the inflation device.The sprinter legend was connected directly to the inflation device.Negative prep was performed with the first sprinter legend balloon with no issues noted.The lesion was not pre-dilated.The device did not pass through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It was reported that the device fractured/cracked at the luer/hub.The crack was not noted prior to attaching the luer of the sprinter legend to the inflation device.It was stated that when attempting to inflate, the contrast sprayed out of the hub.The device was not kinked and restraightened during use.The patient was reported to be alive with no injury.
Additional Manufacturer Narrative
Product analysis summary: a longitudinal crack was noted on the front of the luer.Mould lines were visible on the back of the luer.The balloon folds were intact.No evidence of contrast in the balloon or inflation lumen.Deformation was noted to the distal tip.The device failed negative prep; liquid was noted exiting through the crack on the luer.No other damage was noted to the remainder of the device.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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: 11106901
• Report Number: 9612164-2021-00001
• Device Sequence Number: 17068359
• Product Code: LOX
• UDI-Device Identifier: 00643169271777
• UDI-Public: 00643169271777
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2021

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: 10/06/2022
• Device Model Number: SPL12515X
• Device Catalogue Number: SPL12515X
• Device Lot Number: 218648181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 01/04/2021
• Supplement Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 124