MAUDE Adverse Event Report: IMPERATIVE CARE. INC ZOOM¿ 88 LARGE DISTAL PLATFORM; GUIDE CATHETER

Model Number	ICAC088095
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, the retraction was reported as harder than normal based on having to pull through the patient's tortuous anatomy.The device was discarded after use and therefore not available for return and investigation.There were no device deficiencies reported related to the tracstar.The lot number was not provided by the user facility.All devices undergo testing and inspection confirming devices meet specifications prior to release.
Event or Problem Description
The patient was undergoing a venous stenting case.Upon completion of the case and during retraction, the distal portion of the tracstar got caught on the previously deployed stent and broke several centimeters from the distal end of the catheter in the internal jugular.The patient reportedly had a very zig-zag tortuous anatomy.The distal portion of the catheter was retrieved with a snare.Patient was reported to be doing fine and no complications were reported.The physician did not report any issues with the tracstar.During follow-up, the physician informed that the short sheath was in the "z" or zig-zag shape in the body as a factor for the tracstar shaft being broken.The retraction was harder than normal based on having to pull through this tortuous "z".

• Brand Name: ZOOM¿ 88 LARGE DISTAL PLATFORM
• Common Device Name: GUIDE CATHETER
• Manufacturer (Section D): IMPERATIVE CARE. INC; 1359 dell avenue; campbell CA 95008 6609
• Manufacturer (Section G): IMPERATIVE CARE, INC; 1359 dell avenue; campbell CA 95008 6609
• Manufacturer Contact: joy patel ; 1359 dell avenue; campbell, CA 95008-6609
• MDR Report Key: 14877123
• Report Number: 3014590708-2022-00012
• Device Sequence Number: 5690144
• Product Code: QJP
• UDI-Device Identifier: 00812212030337
• UDI-Public: 812212030337
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K212224
• 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): 06/30/2022

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: ICAC088095
• Device Catalogue Number: ICAC088095
• 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: 06/01/2022
• Initial Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: CAROTID STENT; GUIDEWIRE; SHORT SHEATH; SNARE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 3 YR
• Patient Sex: Female