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

Model Number ICRC071137

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

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

Event Date 08/16/2023

Event Type  malfunction  

Manufacturer Narrative

Imperative care, inc.Received the zoom 71 which had a third-party stent retriever trapped within the lumen of the catheter shaft.Investigation confirmed shaft breakage and suggested that an axial force was applied during the procedure resulting in compression of the distal segment as well as separation of it from the proximal segment of the catheter.The distal segment appeared buckled and crushed along its length.Investigation determined that the catheter jacket had broken and a section of coils that make up the catheter shaft at the break location became exposed.The exposed coils held the distal segment to the remainder of the catheter.Both the broken catheter jacket and exposed coils exhibited minimal stretching.Based on the reported complaint information, case images, and device investigation the most probable cause for the complaint is attributed to retraction of adjunctive devices against resistance within tortuous anatomy with a presence of calcification.The manufacturing records for the zoom 71 were reviewed and demonstrated that the product met all the design and manufacturing specifications.

Event Description

A 95-year-old female was treated for an occlusion in the m2 segment.The patient's anatomy exhibited tortuosity and calcification.Access was obtained with a guidewire and a zoom 88 access catheter.During the first pass, a zoom 35 followed by a zoom 71 catheter were advanced through the zoom 88.The zoom 71 was positioned at the face of the clot and then the zoom 35 was removed from the patient.Aspiration was applied to the zoom 71 and the catheter was then removed.A follow-up contrast run revealed residual clot remained.During the second pass, the same zoom 88 and zoom 71 were used.A third-party microcatheter, and stent retriever were advanced through the zoom 71 to the clot in the m2 segment.No aspiration was applied.The microcatheter, stent retriever, and zoom 71 were then removed.Another contrast run was performed, revealing residual clot.During the third pass, the same microcatheter, stent retriever, zoom 71 and zoom 88 were used.The zoom 88 was advanced to the distal m1 segment.The zoom 71 and stent retriever were advanced once again to the clot in the m2 segment.The clot was removed successfully.While retracting the stent retriever into the zoom 71 through the m2/m1 segment, the physician reported "some friction".As a result, the physician decided to remove the stent retriever and zoom 71 from the patient as a system.The entire system was then placed on the back table.Upon examining the zoom 71, it was discovered that a distal potion of the catheter shaft had separated with the stent retriever in the distal and proximal ends of the catheter.The physician believed the zoom 71 had fractured during removal from the m2/m1 segment due to the noted "friction".No kinks were observed on the access catheter.All components of the zoom 71 catheter and stent retriever were present; no parts were left inside the patient.The patient achieved complete reperfusion with a tici 3 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: 17739646
• MDR Text Key: 323323152
• Report Number: 3014590708-2023-00028
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00812212030450
• UDI-Public: 00812212030450
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211476
• 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: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2024
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2304602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2023
• 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: ARISTOTOLE 24 GUIDEWIRE; EMBOTRAP STENT RETRIEVER; HEADWAY 27 MICROCATHETER; ZOOM 35; ZOOM 88
• Patient Age: 95 YR
• Patient Sex: Female