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

Model Number	ICRC071137
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is available for return but has not yet returned.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 met minimum tensile specification and is kink resistant.The mid shaft section undergoes 100% visual inspection and is free of visual defects or kinks.At this time, the cause of the break is unknown.
Event or Problem Description
A thrombectomy was performed to treat occlusion in the right segment of the middle cerebral artery (mca).The access catheter was delivered over an intermediate catheter and 035 guidewire to access the right common carotid.Imaging demonstrated an extremely tortuous takeoff from the aortic arch.After two initial passes with a zoom 71 reperfusion catheter, the physician noted kink at two locations within the access catheter - one in the distal segment and another in the mid shaft.Zoom 71 reperfusion catheter encountered resistance which prompted the removal of the zoom 71 for a new zoom 71.After the first pass with the new zoom 71, he encountered significant resistance when pulling back.The outer shaft ended up breaking within the patient without separating.The physician proceeded to remove the access catheter and zoom 71 reperfusion catheter as one unit, and was able to remove the zoom 71 reperfusion catheter from the access catheter after straightening the kink.There was no adverse event or negative patient outcome.The patient is doing fine post procedure.

• Brand Name: ZOOM REPERFUSION CATHETER
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): IMPERATIVE CARE INC; 1359 dell avenue; campbell CA 95008 6609
• MDR Report Key: 11023335
• Report Number: 3014590708-2020-00008
• Device Sequence Number: 1047379
• Product Code: NRY
• UDI-Device Identifier: 00812212030061
• UDI-Public: (01)00812212030061(17)210205(10)F2003401
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K202182
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/05/2021
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2003401
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1