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

Model Number	ICRC045144
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Gastritis (1874); Perforation of Vessels (2135); Hernia (2240)
Date of Event	09/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was discarded after use and therefore not available for return and investigation.All devices undergo appropriate testing and inspection per standard manufacturing processes to ensure the device meets specifications prior to release.There were no device deficiencies reported related to the zoom 45 catheter.The cause of the vessel rupture and subsequent brain herniation is unknown.All images from this case were reviewed and there was no evidence of extravasation until after the third pass.Based on operative notes, resistance was encountered on the third pass when advancing the guidewire.The subsequent contrast run was completed through the third party microcatheter and extravasation was then noted.Case images confirmed that the vessel rupture was near the tip of the third party microcatheter in the distal left pca and that the zoom 45 was in the mid basilar artery proximal to the location of the vessel rupture.Based on the positioning of the devices during the contrast run through the microcatheter and the timing described in the operative notes, it is unlikely the zoom 45 caused the rupture.The vessel rupture was most likely caused by the guidewire and/or the third party microcatheter; however, it cannot conclusively be determined that the zoom 45 did not contribute to the vessel rupture.
Event or Problem Description
A 60-year-old male was treated for an occlusion that extended from the basilar artery to the left posterior cerebral artery (pca).Access was obtained with a zoom 88 access catheter over a guide wire.A zoom 71 and a third party microcatheter were advanced over a guidewire through the zoom 88.After positioning the zoom 71, microcatheter, and guidewire in the left pca, the zoom 88 was advanced to the left pca.The guidewire, third party microcatheter, and zoom 71 were then removed from the patient and aspiration was applied to the zoom 88 for approximately two minutes.The clot in the basilar artery was removed; however, the pca remained occluded.A second pass was completed with a zoom 45 catheter, a third party microcatheter, and a guidewire advanced through the same zoom 88 and positioned in the left pca.The zoom 88 was then advanced to the left pca.The third party microcatheter and guidewire were then removed.Aspiration was applied for approximately two minutes to the zoom 45 and zoom 88 catheters, but no clot was removed.The left pca remained occluded.A third pass with the same zoom 88, zoom 45, third party microcatheter, and guidewire was completed.While advancing the guidewire, significant resistance was noted.Contrast was injected through the microcatheter, and extravasation (indicative of a vessel rupture) was observed in the left pca.The guidewire was removed and replaced with another type of guidewire that allowed an occlusion balloon to be delivered to the site of the vessel rupture.Using the third party microcatheter and zoom 45 to support delivery, the occlusion balloon was positioned with the distal end in the left pca and the proximal end in the basilar artery.The occlusion balloon was inflated for approximately five to six minutes then removed.No further extravasation was observed and the left pca remained occluded.Subsequently, the procedure was aborted.The next day, brain herniation was noted resulting from either the hemorrhagic transformation from the baseline stroke or hemorrhage from the vessel rupture.The patient was treated with a ventriculostomy.15 days post procedure, during a planned endoscopy to place a peg feeding tube, the patient was diagnosed with gastritis.It is unknown if treatment was provided for the gastritis.The patient was reported alive as of (b)(6) 2023.There was no report of a device malfunction.

• Brand Name: ZOOM REPERFUSION CATHETER
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): IMPERATIVE CARE. INC; 1359 dell avenue; campbell CA 95008 6609
• Manufacturer (Section G): IMPERATIVE CARE, INC.; 1359 dell avenue; campbell CA 95008 6609
• Manufacturer Contact: joy patel ; 1359 dell; campbell, CA 95008-6609
• MDR Report Key: 17014432
• Report Number: 3014590708-2023-00017
• Device Sequence Number: 20565047
• Product Code: NRY
• UDI-Device Identifier: 00812212030276
• UDI-Public: 00812212030276
• 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): 05/26/2023

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: 08/24/2023
• Device Model Number: ICRC045144
• Device Catalogue Number: ICRC045144
• Device Lot Number: F2221601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARISTOTLE 24 MICROWIRE; ARISTOTLE 34; PHENOM 27 MICROCATHETER; SCEPTER XC BALLOON; ZOOM 71; ZOOM 88
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male