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 12/22/2021

Event Type  malfunction  

Event Description

The patient was undergoing a thrombectomy procedure to treat a basilar occlusion.Since both iliac arteries were occluded, access was obtained through the left radial artery.A sharp bend was noted off the subclavian artery.Zoom 88 was advanced to the distal cervical vertebral artery without any issues.First pass was made successfully using zoom 71 opening the basilar and one posterior cerebral artery (pca).During second pass attempt, resistance was noted when advancing the same zoom 71 through the zoom 88.Zoom 71 was removed and the physician decided to replace it with a competitor catheter.Since resistance was felt when advancing the competitor catheter, the physician decided to end the case without completing the pass as tici 2b was achieved.Several days later, computed tomography angiography (cta) showed a foreign body in the left pca.Clinical decision was made to not remove the fragment.The physician reviewed the imaging from the case and noticed a tip.Per the physician, it is unknown if the tip was detached from the zoom or the competitor's device.There was no intervention performed and no patient sequalae reported.Note that there were two voluntary medwatch reports with user facility number (b)(4) received from fda on (b)(6) 2021.A review of the fda maude database showed that both reports were posted.The risk manager who was listed on the medwatch report was contacted and confirmed that there was only one event.Per their hospital protocol, he had submitted one via us postal service and one electronically.

Manufacturer Narrative

Zoom 71 catheter was discarded by the customer.Therefore, a physical investigation of the device cannot be performed by imperative care.The images provided by the customer were reviewed and compared with internal x-ray images obtained of zoom 71 and competitor device.Based on our comparison the tip images provided by the site is not consistent with zoom 71 tip.However, we cannot conclusively confirm that the tip is not from the zoom 71 catheter.Currently, the cause of the break is unknown.Based on the event description, a sharp bend was noted off the subclavian artery and resistance was encountered when advancing the zoom 71 and competitor catheter through zoom 88.The zoom 71 instructions for use warns the user: "exercise care when manipulating the device through tortuous anatomy.Do not advance or withdraw the zoom catheter or accessory/adjunctive devices against resistance without careful assessment of the cause under fluoroscopy.If the cause cannot be determined, withdraw all devices as a single unit.Excessive manipulation or torqueing the device against resistance may result in damage to the vasculature or the device." the manufacturing records of this lot were reviewed and did not reveal any issues pertaining to design, manufacturing, or quality.Appropriate testing and inspection were completed to ensure the device met minimum tensile specification and is kink resistant.The distal section undergoes 100% visual inspection and is free of visual defects or protrusions.

• 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 avenue; campbell, CA 95008-6609
• MDR Report Key: 13062084
• MDR Text Key: 290158909
• Report Number: 3014590708-2021-00016
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00812212030191
• UDI-Public: 00812212030191
• 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: Other,Health Professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2022
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2021
• 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
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 64 KG