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

Model Number ICRC035158

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Extravasation (1842); Vascular Dissection (3160)

Event Date 02/18/2021

Event Type  Injury  

Manufacturer Narrative

The device was discarded after use and therefore not available for return and investigation.The lot number was not provided by the user facility.However, based on the lots shipped to the user facility around the time of the event, the manufacturing records for 2 lots were reviewed and did not reveal any issues pertaining to design, manufacturing or quality.Appropriate testing and inspection was completed to ensure the device met visual and dimensional requirements.The distal section undergoes 100% visual inspection and is free of visual defects or protrusions.All devices are required to meet lot release testing, which includes visual and dimensional specifications.Catheters are 100% inspected for id, od, effective length, tip length and are to be free of visual defects, during in-process inspection and during quality inspection after manufacturing.Based on the information provided, it is unknown if the device caused or contributed to the reported event.This report is associated with mfg report number: 3014590708-2021-00005.

Event Description

The patient was undergoing a thrombectomy procedure to treat a stroke in the left m1.Access was obtained through the right radial artery into the left cervical carotid using a 8f ballast long sheath.A combination of aristotle guidewire, zoom 35 and zoom 71 was advanced to the clot.The first attempt was unsuccessful, the aristotle 24 wire was advanced further to catheterize the m1.While advancing the aristotle 24 wire, it appeared that the wire was traveling outside the previous path of the vessel.A contrast injection confirmed that the vessel had a small dissection.The dissection was observed at left mid m1.At this time, the 8f ballast was parked at the distal left cervical carotid, zoom 71 and zoom 35 catheters were parked at proximal m1.The physician then treated the extravasation with a stent.Post extravasation treatment, the physician used the same zoom 71 and zoom 35 combination for an additional 2 passes and was able to achieve reperfusion with a tici score of 2b.The patient was reported to be stable post procedure.Physician stated that it was inconclusive what device contributed to the dissection, but likely the guidewire was most involved.Both zoom 71 and zoom 35 were used to remove the clot and no further trauma to the vessel was observed.

• Brand Name: ZOOM REPERFUSION CATHETER
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): IMPERATIVE CARE; 1359 dell avenue; campbell CA 95008 6609
• Manufacturer (Section G): IMPERATIVE CARE; 1359 dell avenue; campbell CA 95008 6609
• Manufacturer Contact: justin ou ; 1359 dell ave; campbell, CA 95008-6609 ; 6692003985
• MDR Report Key: 11486190
• MDR Text Key: 247032432
• Report Number: 3014590708-2021-00004
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00812212030207
• UDI-Public: 00812212030207
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202182
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ICRC035158
• Device Catalogue Number: ICRC035158
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other; Required Intervention