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

Catalog Number SPL30010X

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2022

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess performance of the euphora, solarice, nc euphora, nc solarice and sprinter legend poba balloon catheters everest inflation device <(>&<)> accessories.Survey results are from an cardiovascular surgeon in practice 7 years.In the past two months, the physician has used nc euphora, euphora rx, sprinter legend and everest devices.The physician uses approximately 10 nc euphora devices, 7 euphora rx devices, 10 sprinter legend devices and 30 everest devices in an average month.During one procedure one sprinter legend balloon catheter and one everest inflation device were used to treat a patient with acute c oronary syndrome and with heavy plaque/calcium.The sprinter device was used for angioplasty alone.It was reported that deflation difficulties and removal difficulties occurred during use of the sprinter legend device in vivo.Intervention was not required.It was suggested by the physician that the balloon was not fully deflated but the device was eventually removed with no issues.The everest device was used twice for inflation of the balloon catheter and performed as expected.A piton y adaptor was used with the everest device.There is no complaint against the everest device.No patient injury reported.

• Brand Name: SPRINTER LEGEND RX
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY,
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14355124
• MDR Text Key: 291373938
• Report Number: 9612164-2022-01769
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P790017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SPL30010X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female