MAUDE Adverse Event Report: IMPERATIVE CARE INC ZOOM REPERFUSION CATHETER; CATEHTER, 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	04/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The facility has not yet provided confirmation if the device is available for return.The manufacturing records for this lot did not reveal any issues pertaining to design, manufacturing, or quality.All lot acceptance activities have been met, and appropriate sampling and inspection was completed to ensure the devices in the lot met specifications.At this time, without return of the device, limited images and information available from the hospital, the root cause of tip separation is unknown.If additional information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient was undergoing a stroke case with basilar occlusion.Access was obtained with a competitor access catheter utilizing a radial approach.The zoom 71 was advanced to the target clot location with a competitor microcatheter and 0.014" guidewire, but was wedged into the diseased plaque in the vertebral artery.While attempting to pull out the zoom 71 the operator encountered resistance, and upon further retraction the zoom 71 released.Inspection of the removed zoom 71 resulted in the tip being observed as separated.The operator attempted to retrieve the separated tip with a competitor stent retriever and was unsuccessful.The operator then attempted to advance a competitor intermediate catheter with a new access catheter and microcatheter, but was also unable to navigate to the site of the occlusion.The case was concluded after use of the competitor intermediate catheter.The patient status is currently unknown.

• Brand Name: ZOOM REPERFUSION CATHETER
• Common Device Name: CATEHTER, THROMBUS RETRIEVER
• Manufacturer (Section D): IMPERATIVE CARE INC; 1359 dell avenue; campbell CA 95008 6609
• MDR Report Key: 11886573
• Report Number: 3014590708-2021-00007
• Device Sequence Number: 11090234
• Product Code: NRY
• UDI-Device Identifier: 00812212030191
• UDI-Public: (01)00812212030191(17)220304(10)F2104102
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K210996
• 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): 05/26/2021

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: 03/04/2022
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2104102
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 05/26/2021
• 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
• Patient Age: 71 YR
• Patient Weight: 82