MAUDE Adverse Event Report: IMPERATIVE CARE INC PRODIGY THROMBECTOMY SYSTEM; PRODIGY TWIST 8F

Model Number	TWIST8F
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Stenosis (2263); Obstruction/Occlusion (2422)
Date of Event	03/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the device investigation, third party material failure analysis, and additional information provided by the user, the fracture and deformation of the twist tip from wire was consistent with ductile compression (bending) and torsion overload from twist distal shaft prolapse and excessive twist usage.On the first pass, 7-10 cycles were conducted with the twist and 3-5 cycles on the second pass.Each cycle typically consists of 5 extensions and retractions of twist while rotating in the clockwise direction and 5 extensions and retractions of twist without rotation.The twist was extended and retracted approximately 100-150 times during procedure.A review of lot history record determined that product met design and manufacturing specifications at the time of product release.
Event or Problem Description
The intravascular procedure began with contralateral access with an 8f pinnacle sheath in the left groin.A series of third-party catheters, sheaths, and wires were utilized to access the graft location with no reported challenges.Once access to the intended location was obtained, the 8f prodigy catheter was used to complete three aspiration passes with no clot capture and minimal blood loss.The prodigy catheter was not long enough to reach the distal portion (including the distal anastomosis) of the graft.Two additional passes were completed with the 8f prodigy twist by rotating the twist handle clockwise with one hand.On the first pass with the twist, 7-10 cycles were conducted.The movement of twist was monitored intermittently under fluoroscopy and felt smooth to the physician with no tactile variation.On the second pass with twist, 3-5 cycles were conducted.Separation of twist tip was noted when distal markers on the twist tip did not move as anticipated under fluoroscopy.Twist tip was located by fluoroscopy in the graft lumen.Several attempts were made to aspirate separated tip through the catheter but unsuccessful.A stent was deployed in the graft to trap the twist tip between the stent and the interior wall of the graft.Use of the prodigy system did not result in clearing or aspirating any thrombus.The patient was put on thrombolytic drip overnight, which partially cleared residual thrombus.Ballooning was required after lysis to remove clot in the anastomosis sites.Patient was discharged after observation with no adverse health consequences.

• Brand Name: PRODIGY THROMBECTOMY SYSTEM
• Common Device Name: PRODIGY TWIST 8F
• Manufacturer (Section D): IMPERATIVE CARE INC; 1359 dell avenue; campbell, ca CA 95008 6609
• Manufacturer (Section G): IMPERATIVE CARE INC.; 1359 dell avenue; campbell CA 65008 6609
• Manufacturer Contact: joy patel ; 1359 dell avenue; campbell, CA 95008-6609 ; 2562650412
• MDR Report Key: 19099125
• Report Number: 3014590708-2024-00013
• Device Sequence Number: 20668524
• Product Code: QEW
• UDI-Device Identifier: 00850032079150
• UDI-Public: 00850032079150
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/12/2024

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 Expiration Date: 06/30/2025
• Device Model Number: TWIST8F
• Device Lot Number: 020697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose