MAUDE Adverse Event Report: IMPERATIVE CARE. INC ZOOM REPERFUSION CATHETER; CATHETER, THROMBUS RETRIEVER

Model Number	ICRC055137
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product is not available for return as it is retained by the hospital risk management department.The manufacturing records for this lot were reviewed and did not reveal any issues pertaining to design, manufacturing, or quality.As the device was not returned the exact root cause of the shaft breakage could not be determined.
Event or Problem Description
An 82-year-old female was treated for an occlusion at the m1/m2 segment.Access was obtained with a competitor guide catheter and was parked at the mid-cervical internal carotid artery (ica).After noticing a bend in the mid-cervical, the physician did not attempt to advance the guide catheter further.During first pass, the physician advanced a competitor aspiration catheter and a stent retriever through the guide catheter, opening the m1 segment.The physician then removed the aspiration catheter and stent retriever.In the second pass, the physician advanced a zoom 55 aspiration catheter over a zoom 35 aspiration catheter to the face of the clot at the m2 segment.While placing the zoom 35 catheter at the m2 branch, the physician felt resistance but indicated it was nothing out of the ordinary.The zoom 35 catheter was removed prior to aspiration in m2.Aspiration started and during removal of the zoom 55, the physician believed the catheter shaft broke as there was no tip movement noted.A snare was used to successfully capture and remove the separated zoom 55 piece from the patient.A replacement zoom 55 catheter was used to successfully remove the clot and complete the procedure.Tici 2c score was achieved.There were no patient sequelae reported.The patient passed away approximately 2 days after the procedure.The physician attributed the death to deteriorating patient condition.
Additional Manufacturer Narrative
Imperative care, inc.Received the zoom 55 catheter involved with this complaint and completed the device evaluation.Investigation confirmed the shaft breakage and suggested that an axial force was applied during the procedure, stretching the shaft materials prior to the device breaking.The manufacturing records for the zoom 55 catheter were reviewed, and demonstrated the product met all the design and manufacturing specifications.Based on the information provided and device investigation, the exact root cause could not be determined.

• Brand Name: ZOOM REPERFUSION CATHETER
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): IMPERATIVE CARE. INC; 1359 dell avenue; campbell CA 95008 6609
• Manufacturer (Section G): IMPERATIVE CARE INC.; 1359 dell ave; campbell CA 65008 6609
• Manufacturer Contact: joy patel ; 1359 dell avenue; campbell, CA 95008-6609
• MDR Report Key: 16414815
• Report Number: 3014590708-2023-00003
• Device Sequence Number: 3364620
• Product Code: NRY
• UDI-Device Identifier: 00812212030474
• UDI-Public: 00812212030474
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K210996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2023

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: 12/01/2023
• Device Model Number: ICRC055137
• Device Catalogue Number: ICRC055137
• Device Lot Number: F2233201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2023
• Supplement Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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: BENCHMARK BMX 96; EN SNARE,; PENUMBRA (BRAND; RED 62 CATHETER; RED 72 CATHETER; SOFIA CATHETER; SOLITAIRE STENT RETRIEVER (MEDTRONIC); VELOCITY MICROCATHETER; ZOOM 35; ZOOM 55
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female