MAUDE Adverse Event Report: IMPERATIVE CARE INC. PRODIGY TWIST

Model Number	TWIST8F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	09/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The 8f prodigy twist was discarded and not returned for investigation.The manufacturing records confirmed the product met the design, manufacturing, and quality specifications.Based on the information provided, the cause of the dissection is unknown.There was no allegation against the 8f prodigy twist, and no device issues reported during the procedure.As multiple devices were involved in the reported event, a related mdr was submitted for the same patient and incident under reference number 3014590708-2025-00037.
Event or Problem Description
It was reported that the superficial femoral artery (sfa) was treated using a third-party sheath, 8f prodigy catheter, and 8f prodigy twist.The clot was organized.A vessel dissection was diagnosed, which the physician was unaware of until the initial angiogram.The dissection impeded blood flow to the foot.It was determined that the dissection was the primary reason for the lack of flow and was unrelated to the catheter's ability to remove clot.It is unknown whether any additional intervention was performed to address the dissection.There was no malfunction reported during the procedure.

• Brand Name: PRODIGY TWIST
• Common Device Name: PRODIGY TWIST
• 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: 23889524
• Report Number: 3014590708-2025-00038
• Device Sequence Number: 13167338
• Product Code: QEW
• UDI-Device Identifier: 00850032079150
• UDI-Public: (01)00850032079150(17)250630(10)020697
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 12/24/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: TWIST8F
• Device Catalogue Number: TWIST8F
• Device Lot Number: 020697
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2023
• 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: 8F PRODIGY CATHETER.; TERUMO DESTINATION SHEATH.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown