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

Model Number ICRC055137

Device Problems Break (1069); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/08/2023

Event Type  Injury  

Manufacturer Narrative

The proximal segment of the zoom 55 catheter was returned for investigation.Investigation demonstrated damage to the catheter shaft materials which suggests that an axial force was applied during the procedure, stretching the shaft materials prior to the device breaking.Investigation demonstrated stretched coil at the break location.Multiple kinks were also present in the proximal section of the returned catheter.The distal segment of the zoom 55 was not returned, but a photo of the separated piece was provided.The photo showed the zoom 55 distal segment with the marker band deformed and a second unknown much larger metallic type piece.The second piece was not part from the zoom 55 as there are no other metallic sections of the catheter on the distal end of that size.Additional follow up was conducted with the physician, however he commented he did not know what the metallic type piece was, when it was removed from the patient, and if it may have interacted with the zoom 55 or zoom 88 catheters.The complaint investigation was not able to determine the exact root cause.Based on the reported complaint information and investigation the tortuous anatomy likely contributed to the complaint.The lot number for the complaint device was reported as unknown by the site.The manufacturing records for the three most recent zoom 55 lots shipped to the site prior to the complaint aware date were reviewed and demonstrated that all lots met the design and manufacturing specifications.

Event Description

A female patient was treated for an occlusion at the m2 segment.The patient was noted to have a "tortuous neck".Access was obtained using a guidewire and a zoom 88 access catheter.During the first pass, a zoom 55 catheter was advanced through the access catheter and over a zoom 35 to the face of the clot.The zoom 35 and guidewire were removed.Aspiration was applied to the zoom 55 for approximately 90 seconds.Resistance was felt while retracting the zoom 55 through the zoom 88, which was positioned in the petrous.Both the zoom 55 and zoom 88 catheters were removed from the patient as a system.The physician then observed (under imaging) the tip of the zoom 55 in the a2 segment.Using the same guidewire and zoom 88, the physician attempted to advance two stent retrievers through the access catheter to try and capture the separated zoom 55 tip.After multiple unsuccessful attempts, both stent retrievers were removed.A new zoom 55 catheter was successfully used to retrieve the separated segment and the second zoom 55 catheter was then removed from the patient.The physician continued with the procedure using a zoom 71 and the same zoom 35, guidewire, and zoom 88, without any issue.The clot was successfully removed.The patient achieved partial reperfusion with a tici 2b score and remains in stable condition.No patient sequelae were reported.

• Brand Name: ZOOM REPERFUSION CATHETER
• Type of Device: 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: 17908478
• MDR Text Key: 325340559
• Report Number: 3014590708-2023-00029
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00812212030474
• UDI-Public: 00812212030474
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ICRC055137
• Device Catalogue Number: ICRC055137
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ARISTOTLE GUIDEWIRE; COMANECI; SOLITAIRE; ZOOM 35; ZOOM 71; ZOOM 88
• Patient Outcome(s): Required Intervention
• Patient Sex: Female