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

Model Number	ICRC055137
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Inspection results of the returned device confirmed that the catheter was separated mid shaft.The separated catheter length measured at 30.0cm, and the remaining shaft measured at 108.9cm.There were no kinks or damages to the device other than the ovalized distal tip and the shaft separation.The manufacturing records of 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.The catheter undergoes 100% visual inspection for visual defects over the entire length of the catheter.
Event or Problem Description
Patient presented with sagittal sinus thrombosis.Access was obtained with a zoom 88 advanced over a competitor support catheter and 0.035 guidewire in the transverse sinus.Zoom 55 was subsequently advanced to the clot and hooked up to the aspiration pump for mechanical thrombectomy.Once under aspiration, the physician rapidly advanced and retracted the zoom 55 within the sagittal sinus for approximately 15 seconds.During the zoom 55 removal it was observed that the mid shaft separated, with approximately 20cm of distal shaft remaining in the patient.The physician proceeded to remove the separated distal shaft by inflating a balloon catheter and anchoring the separated zoom 55 segment, and subsequently retracting it into the guide catheter.The physician completed the procedure with a new zoom 71.Patient is currently stable and doing well.

• 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: 12112503
• Report Number: 3014590708-2021-00009
• Device Sequence Number: 4600708
• Product Code: NRY
• UDI-Device Identifier: 00812212030283
• UDI-Public: (01)00812212030283(17)220302(10)F2105401
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/29/2021

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: 03/02/2022
• Device Model Number: ICRC055137
• Device Catalogue Number: ICRC055137
• Device Lot Number: F2105401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 07/02/2021
• 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