MAUDE Adverse Event Report: IMPERATIVE CARE INC. ZOOM REPERFUSION CATHETER

Model Number	ICR071137
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A 56-year-old female patient was treated for an occlusion at the m1 segment.Access was obtained with a guidewire and a zoom 88 catheter.During the first pass, a zoom 71 catheter and a stent retriever were advanced to the m1 segment.After aspiration was applied, the stent retriever was retracted into the zoom 71.Both devices were then pulled back and removed together through the zoom 88.The physician stated that while pulling back the devices through the zoom 88, the devices got stuck in the y adapter of the third party rotating hemostatic valve (rhv).The physician continued retracting the devices resulting in the zoom 71 shaft separating.The physician confirmed that the separation occurred outside of the patient.A second pass was completed using a new zoom 71 catheter.It was advanced over the same guidewire, through the same rhv, and same zoom 88 catheter.The same stent retriever was then advanced through the new zoom 71 to the m1 segment, and the same steps as the first pass were performed.After aspiration was applied, the physician again retracted the stent retriever into the zoom 71 and pulled both devices back together through the zoom 88 and rhv.The devices became stuck in the rhv again.The physician continued to retract the zoom 71 and stent retriever and was able to remove them.Upon inspection of the second zoom 71, the physician reported that the distal portion of the catheter was stretched and mangled.According to the physician, there were no issues with the zoom devices and indicated that the rhv may have been too tight during removal of the zoom 71 and stent retriever.No further passes were attempted.The m1 clot was partially removed, and a final tici 2c score was achieved.No patient sequelae were reported.
Additional Manufacturer Narrative
The manufacture records for the zoom products were reviewed.The review confirmed all devices met the manufacturing and quality requirements.The devices involved in the case have not been returned for investigation.Although the exact root cause cannot be determined, the most likely cause based on the initial input from the physician and initial images of the devices is the tightened rhv limited the ability of the zoom 71 with the stent retriever inside to be removed without damaging the zoom 71 resulting in the zoom 71 separating.
Additional Manufacturer Narrative
A proximal segment of the zoom 71 was returned for evaluation, the reported separated distal segment was not returned for investigation.The investigation of the returned proximal segment demonstrated damage which suggests an axial force was applied during the procedure, resulting in stretching of shaft materials prior to the device breaking.Investigation demonstrated stretched coil and catheter jacket at the break location.Additionally, one kink was present on the returned catheter segment.Based on the returned device investigation with the prior information provided by the user, the most likely root cause was the tightened rhv limited the ability of the zoom 71 with the stent retriever inside to be removed without damaging the zoom 71 resulting in the zoom 71 separating.

• Brand Name: ZOOM REPERFUSION CATHETER
• Common Device Name: ZOOM REPERFUSION CATHETER
• Manufacturer (Section D): IMPERATIVE CARE INC.; 1359 dell ave; campbell CA 95008 6609
• Manufacturer (Section G): IMPERATIVE CARE INC.; 1359 dell ave; campbell CA 95008 6609
• Manufacturer Contact: joy patel ; 1359 dell ave; campbell, CA 95008-6609 ; 4082029060
• MDR Report Key: 21037093
• Report Number: 3014590708-2024-00041
• Device Sequence Number: 8456999
• Product Code: NRY
• UDI-Device Identifier: 00812212030450
• UDI-Public: (01)00812212030450(17)270625(10)F2417304
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K211476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ICR071137
• Device Catalogue Number: ICR071137
• Device Lot Number: ICR071137
• 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: 12/04/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2024
• 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: BOSTON SCIENTIFIC GATEWAY PLUS Y ADAPTER,; EMBOTRAP STENT RETRIEVER,; SYNCHRO 14 GUIDEWIRE; ZOOM 88 ACESS CATHETER
• Patient Age: 56 YR
• Patient Sex: Female