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

Model Number	ICRC045144
Medical Device Problem Codes	Break (1069); Material Separation (1562)
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 zoom 45 catheter was returned for investigation.Upon investigation it was determined that shaft breakage occurred at the distal end of the catheter.Investigation demonstrated stretching and kinking along the distal segment.The proximal segment of the zoom 45 was observed to have a section of stretched outer jacket at the break location.Based on the information provided and device investigation the exact root cause could not be determined.The manufacturing records for the zoom 45 were reviewed, and demonstrated the product met all the design and manufacturing specifications.
Event or Problem Description
A 66-year-old female patient was undergoing a thrombectomy procedure to treat an occlusion in the left m2.A competitor's balloon guide catheter was advanced and parked at the proximal internal carotid artery (ica).The physician advanced the zoom 45 aspiration catheter to the face of the clot.During clot retrieval on the first pass, the physician felt resistance on the zoom 45 while pulling it back inside the guide catheter.The physician noticed a kink in the competitor's guide catheter- approximately 15cm from the distal tip.After applying more retrieval force, the physician felt the resistance give way and was able to remove the zoom 45 catheter from the patient.In a follow-up angiography the physician noticed that a portion of the zoom 45 catheter was still in the patient.The location of the break on the zoom 45 was not specified.A snare was used to successfully capture the zoom 45 piece and remove it from the patient's body.Following the removal of the competitor balloon guide catheter, the physician proceeded the case with different competitor guide catheter.However, the replacement guide catheter also kinked approximately 15cm from the distal tip.The patient's anatomy was found to be tortuous.After spending hours on the procedure and the second guide catheter kinking at a similar location, the physician decided to abort the case.The patient was reported as stable, and no patient sequelae were reported.

• 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: 16414812
• Report Number: 3014590708-2023-00002
• Device Sequence Number: 11604092
• Product Code: NRY
• UDI-Device Identifier: 00812212030276
• UDI-Public: 00812212030276
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 02/21/2023

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: 08/19/2023
• Device Model Number: ICRC045144
• Device Catalogue Number: ICRC045144
• Device Lot Number: F2223001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2022
• 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: 4 MM STENT RETRIEVER.; INFINITY GUIDE CATHETER.; SYNCHRO 2 GUIDE WIRE.; TRACK 21 CATHETER.; WALRUS BALLOON GUIDE CATHETER.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 100 KG