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

Model Number	ICRC071137
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was being treated for a left internal carotid artery (ica) m1 segment occlusion.Access was obtained radially with a competitor access catheter from the right side.The patient was reportedly very tall.The physician attempted to place the access catheter more distal but didn't have enough length.The access catheter's hub was abutted to the wrist.Zoom35 and zoom71 were advanced to the target clot location.Zoom35 was removed and aspiration was applied.When the physician tried to retract zoom71, the physician noticed that there was no one-to-one movement.At this time the access catheter was not observed on the imaging screen and was out of the ica.The physician believed that the zoom71 had "doubled back" on itself, and that catheter separated upon retraction into the access catheter.Catheter was removed successfully with a 1.5cm snare.The case was completed after one pass and tici 3 was achieved.
Additional Manufacturer Narrative
The device was discarded after use and therefore not available for return and investigation.There were limited images of the case provided.Currently, the cause of the break in unknown.It was reported that during a radial case, the physician was unable to place the access catheter more distally due to not having enough length as the patient was reportedly tall.Zoom reperfusion ifu warns user that "prior to use, ensure that the dimensions (e.G.Diameter and length) of the zoom catheter and accessory/adjunctive devices to be used in the procedure are compatible with each other and appropriate for the target vasculature." since the device was not returned for investigation and with the limited images of the case provided, the exact root cause of the shaft breakage is unknown.The manufacturing records of this lot were reviewed and did not reveal any issues pertaining to design, manufacturing, or quality.Appropriate testing and inspection were completed to ensure the device met minimum tensile specification and is kink resistant.The distal section undergoes 100% visual inspection for visual defects.

• 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 avenue; campbell CA 95008 6609
• Manufacturer Contact: joy patel ; 1359 dell avenue; campbell, CA 95008-6609
• MDR Report Key: 13670846
• Report Number: 3014590708-2022-00003
• Device Sequence Number: 20022540
• Product Code: NRY
• UDI-Device Identifier: 00812212030443
• UDI-Public: 00812212030443
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2022

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 Expiration Date: 11/29/2022
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2132301
• 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: 02/05/2022
• Initial Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2021
• 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: BALLAST; GUIDEWIRE; TREVO 6X37; ZOOM 35
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 108 KG