MAUDE Adverse Event Report: IMPERATIVE CARE INC. PRODIGY TWIST

Model Number	TWIST8F-S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	09/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure utilizing third-party devices, an 8f-s prodigy catheter, and an 8f-s prodigy twist, a vessel dissection was identified.The physician was unable to determine the cause of the dissection.The treated vessels included the right forearm graft and the cephalic vein.There was no device malfunction reported during the procedure.
Additional Manufacturer Narrative
The 8f-s 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 currently unknown.There was no allegation against the 8f-s 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 3014590708-2025-00035.

• 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: 23889290
• Report Number: 3014590708-2025-00036
• Device Sequence Number: 21198371
• Product Code: QEW
• UDI-Device Identifier: 00850032079037
• UDI-Public: (01)00850032079037(17)221231(10)019683
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: 12/31/2022
• Device Model Number: TWIST8F-S
• Device Catalogue Number: TWIST8F-S
• Device Lot Number: 019683
• 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: 09/20/2022
• Initial Report FDA Received Date: 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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-S PRODIGY CATHETER; QUICK CROSS; REGALIA; SV5
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown