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 10/31/2021

Event Type  Injury  

Manufacturer Narrative

The patient was(b)(6) and the devices were discarded.Therefore, a physical investigation of the device cannot be performed by imperative care.Based on the information provided, this was a challenging case with six unsuccessful passes using other devices prior to attempting the thrombectomy with the zoom system.While using the zoom system, the physician reported significant resistance and difficulty navigating around the ophthalmic artery.After a successful thrombectomy, the physician noted that the (b)(6) shaft had fractured while withdrawing the (b)(6)through the (b)(6).Per the instructions for use (ifu), excessive manipulation or torquing 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.The catheter undergoes 100% visual inspection for visual defects over the entire length of the catheter.

Event Description

The patient was undergoing a thrombectomy procedure to treat an occlusion within the right internal carotid artery (ica) terminus and middle cerebral artery (mca) m1 segment.Interventional neurologist attempted six passes with a balloon guide catheter, large bore aspiration catheter (lbc), microcatheter, revascularization catheter and stent retriever.Since the occlusion was not resolved, the physician decided to use the zoom system.Access was obtained through the left groin with an 8f shuttle, a vtk select catheter and a 038 guidewire.(b)(6) was advanced to the clot over the microcatheter and guidewire.Using a 60cc syringe, the physician applied aspiration.The physician then tried to advance (b)(6) to the clot, but it could not pass the patient's ophthalmic artery.He tried rotating (b)(6) to change the orientation of the tip but was unsuccessful.The (b)(6) was then used to perform the thrombectomy.When he tried to retract the (b)(6), he noticed that there was no one-to-one movement (as the physician was pulling back the proximal end the catheter was moving outside the patient, but he didn't not see distal catheter movement on angiography).He observed that the (b)(6) catheter had fractured within the (b)(6) catheter five to seven inches from the (b)(6) distal end.The physician successfully removed the entire (b)(6) catheter.Follow-up angiography confirmed revascularization and (b)(4) was achieved.The patient was reported as stable.There were no other patient sequalae reported.

Manufacturer Narrative

The patient was(b)(6) and the devices were discarded.Therefore, a physical investigation of the device cannot be performed by imperative care.Based on the information provided, this was a challenging case with six unsuccessful passes using other devices prior to attempting the thrombectomy with the zoom system.While using the zoom system, the physician reported significant resistance and difficulty navigating around the ophthalmic artery.After a successful thrombectomy, the physician noted that the zoom71 shaft had fractured while withdrawing the zoom 71 through the zoom 88.Per the instructions for use (ifu), excessive manipulation or torquing 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.The catheter undergoes 100% visual inspection for visual defects over the entire length of the catheter.

Event Description

The patient was undergoing a thrombectomy procedure to treat an occlusion within the right internal carotid artery (ica) terminus and middle cerebral artery (mca) m1 segment.Interventional neurologist attempted six passes with a balloon guide catheter, large bore aspiration catheter (lbc), microcatheter, revascularization catheter and stent retriever.Since the occlusion was not resolved, the physician decided to use the zoom system.Access was obtained through the left groin with an 8f shuttle, a vtk select catheter and a 038 guidewire.Zoom 71 was advanced to the clot over the microcatheter and guidewire.Using a 60cc syringe, the physician applied aspiration.The physician then tried to advance zoom 88 to the clot, but it could not pass the patient's ophthalmic artery.He tried rotating zoom 88 to change the orientation of the tip but was unsuccessful.The zoom71 was then used to perform the thrombectomy.When he tried to retract the zoom71, he noticed that there was no one-to-one movement (as the physician was pulling back the proximal end the catheter was moving outside the patient, but he didn't not see distal catheter movement on angiography).He observed that the zoom71 catheter had fractured within the zoom88 catheter five to seven inches from the zoom71 distal end.The physician successfully removed the entire (b)(6) catheter.Follow-up angiography confirmed revascularization and tici2b was achieved.The patient was reported as stable.There were no other patient sequalae 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 avenue; campbell, CA 95008-6609
• MDR Report Key: 12865768
• MDR Text Key: 286247436
• Report Number: 3014590708-2021-00015
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2022
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2126301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2021
• 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
• Treatment: 038 GUIDEWIRE.; 8F COOK SHUTTLE.; 9F MERCI BALLOON GUIDE CATHETER.; EMBOTRAP.; SYNCHRO2 SUPPORT GUIDEWIRE.; TRAK 21 CATHETER.; TREVO RETIEVER.; VTK SELECT CATHETER.; ZOOM 88.
• Patient Outcome(s): Required Intervention
• Patient Sex: Female