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	01/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The inspection results of the returned device confirmed that the distal tip of the catheter was detached.The returned device did not include the marker band.The detached distal tip was not returned with the device.The remaining shaft measured at 136.9 cm.A kink was present at 34.5 cm from the tip of the remaining shaft.It is uncertain if this kink was present during the procedure or was a result of handling damage after removal from the patient.The manufacturing records for 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 was kink resistant.100% visual inspection was performed on the distal section of the catheter and the distal section was free of defects or protrusions.The root cause of the detachment is unable to be determined.At this time, the cause of the break is unknown.
Event or Problem Description
A thrombectomy was performed to treat occlusion in the left m1 segment of the middle cerebral artery (mca).The access catheter zoom 88-t was delivered over an intermediate catheter and 038 guidewire to the internal carotid artery (ica) terminus.Zoom 71 reperfusion catheter was advanced to the face of the clot, and reperfusion was achieved after the third pass.After the third pass, the physician injected contrast through the zoom 88-t, and under fluoroscopy the physician saw the zoom 71 tip advance from the zoom 88-t to the mca.The physician proceeded to use a stent retriever to remove the zoom 71 tip.There were no further adverse events or negative patient outcome post removal of zoom 71 tip.The patient is stable following the 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: 11211362
• Report Number: 3014590708-2021-00001
• Device Sequence Number: 19747469
• Product Code: NRY
• UDI-Device Identifier: 00812212030191
• UDI-Public: (01)00812212030191(17)211027(10)F2029501
• 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): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/21/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/27/2021
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2029501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2021
• Initial Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ZOOM 88-T, 110CM
• Outcome Attributed to Adverse Event: Required Intervention