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 Code	Perforation of Vessels (2135)
Date of Event	06/08/2021
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.
Event or Problem Description
Patient presented with an m3 middle cerebral artery (mca) occlusion.Access was obtained with a competitor access catheter with purchase in the high cervical segment of the internal carotid artery (ica).A competitor guide wire was advanced until it crossed the clot in m3 mca, and the zoom 35 was advanced to the face of the clot.The m3 mca vessel size was noted to be approximately 1.5mm.One pass was performed, and upon removal of the zoom 35 clot appeared to be on the distal tip.Angiogram performed after the first pass indicated a vessel perforation in the m3 mca.The operator believes the perforation was due to patient movement during the aspiration procedure.The case was concluded and the patient was intubated to manage the bleeding.The stroke self-resolved and patient is currently doing well.

• Brand Name: ZOOM REPERFUSION CATHETER
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): IMPERATIVE CARE INC; 1359 dell avenue; campbell CA 95006 6609
• MDR Report Key: 12136379
• Report Number: 3014590708-2021-00010
• Device Sequence Number: 11615803
• Product Code: NRY
• UDI-Device Identifier: 00812212030207
• UDI-Public: (01)00812212030207(17)220325(10)F2107701
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/07/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/25/2022
• Device Model Number: ICRC035158
• Device Catalogue Number: ICRC035158
• Device Lot Number: F2107701
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 07/08/2021
• 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: Hospitalization