MAUDE Adverse Event Report: IMPERATIVE CARE INC. PRODIGY CATHETER

Model Number	PRODIGY8F
Medical Device Problem Codes	Break (1069); Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The prodigy 8f catheter was returned for investigation.Investigation confirmed marker band detachment and suggested that an axial force was applied to the catheter which pulled the radiopaque marker band through the outer jacket materials resulting in the detachment of the radiopaque marker band from the catheter.Investigation demonstrated tearing of catheter outer jacket material on the catheter shaft near the distal tip.Based on the damage, the distal tip was compressed and collapsed, and the radiopaque marker appeared to have been torn out from the catheter shaft jacket.The radiopaque marker band was not returned for investigation.Based on the complaint information provided the exact root cause could not be determined.However, the prodigy catheter was advanced and withdrawn through a stent, which may have been a contributing factor to the marker band detachment.The manufacturing records for prodigy 8f were reviewed and demonstrated that the product met all the design and manufacturing specifications.
Event or Problem Description
It was reported that during an in-stent restenosis (isr) procedure, the prodigy 8f catheter was used with a third-party sheath and guidewire.After the second pass, the physician noticed the distal tip was missing.Upon fluoroscopy, the marker band was visible inside the stent in the sfa.The physician successfully retrieved the marker band with the use of an additional third-party device.There were no device malfunctions or difficulty tracking the device during the procedure.The patient was stable post procedure, and no patient sequelae was reported.

• Brand Name: PRODIGY CATHETER
• Common Device Name: PRODIGY CATHETER
• Manufacturer (Section D): IMPERATIVE CARE INC.; 1359 dell ave; campbell CA 95008 6609
• Manufacturer (Section G): IMPERATIVE CARE INC.; 1359 dell ave; campbell CA 95008 6609
• Manufacturer Contact: katharine treangen ; 1359 dell ave; campbell, CA 95008-6609 ; 4082029060
• MDR Report Key: 23854634
• Report Number: 3014590708-2025-00031
• Device Sequence Number: 14699850
• Product Code: QEW
• UDI-Device Identifier: 00850032079143
• UDI-Public: (01)00850032079143(17)270731(10)071625-01
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K214114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PRODIGY8F
• Device Catalogue Number: PRODIGY8F
• Device Lot Number: 071625-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HOT SHOT.; MEDTRONIC SPIDER WIRE FILTER.; TERUMO 8F PINNACLE DESTINATION SHEATH.; TERUMO ADVANTAGE GLIDEWIRE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown