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

Model Number ICRC045144

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

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

Event Date 07/19/2023

Event Type  malfunction  

Manufacturer Narrative

The proximal segment of the zoom 45 catheter was returned for investigation.Investigation demonstrated severe damage to the catheter shaft materials and suggested that an axial force was applied during the procedure, stretching the shaft materials prior to the device breaking.Investigation demonstrated stretched coil, and outer jacket at the break location.The exact root cause for the broken shaft could not be determined.The manufacturing records for the zoom 45 were reviewed and demonstrated that the product met all the design and manufacturing specifications.

Event Description

An 85-year-old woman was treated radially for an occlusion at the right m2 segment.The treating physician performed the exchange technique with a 6f sheath and inserted the zoom rdl.The physician then used a 0.035" guide wire and a third party microcatheter.The microcatheter was advanced to the ica (internal carotid artery).The zoom rdl was advanced over the microcatheter to the cca (common carotid artery) and later advanced it to the very proximal ica.The physician did not get the zoom rdl very high due to resistance felt while pushing the catheter out of a type c arch around the 180-degree turn.The microcatheter and 0.035" wire were removed out of the patient.A 0.014" guidewire, different third party microcatheter, and zoom 45 were inserted and advanced to the face of the clot at m2 segment without issue.The zoom rdl was advanced a bit higher (barely proximal to ica) and aspiration was applied to the zoom 45.When the physician did not see any clot in the cannister, the physician retracted the zoom 45 out of the zoom rdl to flush the catheter.There was a lot of resistance and initially the physician could not get the zoom 45 out of the zoom rdl.When the zoom 45 was removed out of the rdl, the physician noticed the distal portion of zoom 45 was broken and the end of the catheter was frayed.The physician turned on the fluoroscopy and did not see the separated piece.The physician decided to exchange the current zoom rdl with a new zoom rdl to flush out the original zoom rdl to see if the broken piece got stuck in it.The original rdl was flushed, and the separated distal part was not located.For the second pass, a new zoom rdl was positioned distal cca/ proximal ica.A zoom 35 and a zoom 55 were inserted and advanced to the clot.Once the zoom 35 and zoom 55 were at the clot, the physician noticed a kink in the zoom rdl under fluoroscopy.Aspiration was performed with the zoom 55.A contrast run showed that the vessel had opened a "little bit".The physician observed additional occlusions; however, they removed all the zoom devices.During the third pass, a third-party guide catheter was advanced to distal cca.A microcatheter, a third-party reperfusion catheter, and a stent retriever were advanced to the clot, and the solumbra technique was performed.The case was completed and a tici 2c score was achieved.The patient was reported to be 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: 17561184
• MDR Text Key: 321635590
• Report Number: 3014590708-2023-00024
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00812212030498
• UDI-Public: 00812212030498
• 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: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2024
• Device Model Number: ICRC045144
• Device Catalogue Number: ICRC045144
• Device Lot Number: F2303701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2023
• 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: 0.035" GUIDEWIRE; 130CM SIMMONS; 3D STENT RETRIEVER; 6F SHEATH; ARISTOTLE 0.014" GUIDEWIRE; FABUKI 6F GUIDE CATHETER; RED 62 REPERFUSION CATHETER; VELOCITY MICROCATHETER; ZOOM 35; ZOOM 45; ZOOM 55; ZOOM RDL
• Patient Age: 85 YR
• Patient Sex: Female