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

Model Number	ICRC035158
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extravasation (1842); Vascular Dissection (3160)
Date of Event	08/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product is not available for return as it was discarded; however, the manufacturing records for this lot were reviewed and did not reveal any issues pertaining to design, manufacturing, or quality.Appropriate testing and inspection was completed to ensure the device tip is atraumatic, and the distal section of the catheter undergoes 100% visual inspection and is free of visual defects or protrusions.At this time, the root cause of the vessel dissection and extravasation is unknown, and it can not be determined if zoom reperfusion catheter caused or contributed to the adverse event.If additional information is received, a supplemental report shall be issued.
Event or Problem Description
The patient was undergoing a thrombectomy procedure on (b)(3) to treat an occlusion in the left m1 and m2 segment of the middle cerebral artery (mca).The imperative care zoom 071 reperfusion catheter was delivered over a zoom 035 reperfusion catheter to the site of occlusion at m1 mca, and on first pass some clot was retrieved with residual clot remaining.Using the same zoom 071 and zoom 035 reperfusion catheter for the second pass, the physician was unable to retrieve additional clot from the m1 and m2 mca location.The physician then observed haziness with no apparent patient response, and the m2 mca artery appeared to be shutting down.The physician was concerned there may have been a dissection and proceeded to remove the zoom 071 and zoom 35 devices from the patient.On the third pass the physician switched to two competitor catheters, but at the clot site encountered extravasation as observed under fluoroscopy with apparent patient responses.The physician subsequently removed all devices, and used a balloon catheter and onyx to treat and occlude the extravasation.The extravasation was then resolved and the operation was concluded.The patient is currently doing well and is better than pre-procedure baselines.

• Brand Name: ZOOM REPERFUSION CATHETER
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): IMPERATIVE CARE INC; 1359 dell avenue; campbell, ca
• MDR Report Key: 10477726
• Report Number: 3014590708-2020-00002
• Device Sequence Number: 16786002
• Product Code: NRY
• UDI-Device Identifier: 00812212030092
• UDI-Public: (01)00812212030092(17)201119(10)IFG051320-01
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K183043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/19/2020
• Device Model Number: ICRC035158
• Device Catalogue Number: ICRC035158
• Device Lot Number: IFG051320-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention