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

Model Number	ICRC035158
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	07/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
An 84-year-old male patient was treated for an occlusion at the left m2 segment.The patient's anatomy was reported to be mildly tortuous.Access was obtained using third-party (0.096" id access catheter), which was parked distal to the bifurcation.During the first pass a third-party aspiration catheter was advanced through the access catheter to the face of the clot and aspiration was applied.Imaging showed a more distal occlusion remained.The third-party aspiration catheter was removed from the patient.During the second pass, the physician advanced a zoom 35 catheter over a guidewire through the third-party access catheter to the face of the clot.Aspiration was applied to the zoom 35.A partial clot was removed.In the third pass, the same zoom 35 was advanced through the access catheter to the face of the clot and aspiration was applied.While removing the zoom 35, resistance was felt at an unknown anatomical location.The zoom 35 was removed from the patient.Imaging showed a partial clot was removed.Inspection of the removed zoom 35 showed the outside coating of the catheter was damaged.The type of the damage was not provided.During the fourth pass, a new zoom 35 was advanced through the same third-party access catheter to the clot.While retracting the zoom 35, resistance was again felt at the same anatomical location.After removing the zoom 35 from the patient, the physician noted the distal portion of the zoom 35 had broken.Imaging showed that the broken segment of the zoom 35 was in the common carotid to the m2 branch.The physician attempted to use a snare to remove the broken segment of the zoom 35 but was unsuccessful.The physician planned to surgically remove the broken segment, however the patient's family refused.The m2 clot was partially removed and a final tici 2b score was achieved.It was determined that the separated distal end was non-flow limiting.The patient was reported in stable condition post procedure without any patient sequelea.
Additional Manufacturer Narrative
Two zoom 35 devices were returned for investigation.Visual inspection of the first zoom 35 used in the case exhibited damage with a series of indentations on the exterior of the distal shaft.The proximal segment of the second zoom 35 device used in the case was returned for investigation.Investigation confirmed the reported shaft break including material elongation at the break location suggesting an axial force was applied.Based on the complaint information provided and without the return of adjunctive devices, the exact root cause for the reported damage and break could not be determined.However, based on the investigation, evidence suggests the zoom 35 catheters had been retracted through a restriction resulting in damage to the catheter shafts.The manufacturing records for the zoom 35 catheters were reviewed and demonstrated that the product met all the design and manufacturing specifications.Per user facility report (mw5157734) filed by the hospital "patient was brought to the (b)(6) for an emergency thrombectomy.An aspiration catheter was being used for thrombectomy, and the aspiration catheter broke off and remained in the m3 segment.Attempts were made to recover the catheter but were unsuccessful.".
Additional Manufacturer Narrative
Based on the user facility report (mw5157734), the event occurred on july 21, 2024, the patient's weight was 78 kg, and the broken segment of the zoom 35 remains in the m3 segment.After following up with the initial reporter of the user facility report, it was confirmed that both the event date and the patient weight listed in the user facility report are accurate.Additionally, the initial reporter clarified that the physician noted the zoom 35 segment remains in the intracranial vessel.

• 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; campbell, CA 95008-6609
• MDR Report Key: 20032657
• Report Number: 3014590708-2024-00028
• Device Sequence Number: 3075598
• Product Code: NRY
• UDI-Device Identifier: 00812212030443
• UDI-Public: 00812212030443
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

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: 06/19/2026
• Device Model Number: ICRC035158
• Device Catalogue Number: ICRC035158
• Device Lot Number: F2410801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2024
• 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: 0.035" GLIDEWIRE; 8.5F SHEATH; ARISTOTLE 0.018"; BMX 0.096"; RED 62; VELOCITY; ZOOM 35
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Hispanic