MAUDE Adverse Event Report: RAPID MEDICAL LTD. TIGERTRIEVER 17

Model Number	TIGERTRIEVER 17
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/18/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
Additional procedural details were obtained from the reporting physician on a teleconference that was held on november 27th, 2023.It was pointed out by the physician that it seems that the device got caught on an undetectable piece of calcium which prevented proper deflation and retrieval.The device was discarded after use and therefore not available for return and investigation, however it was mentioned by the physician that the device was intact and fully deflated when removed from the patient.The physician also mentioned during the call that the patient was pretreated with aggrastat, which could have resulted in an excess bleeding.Based on the results of the investigation, dhr review, and procedure details, there is no indication that the device, labeling or packaging failed to meet its specifications.
Event or Problem Description
Rapid medical received a report regarding the tigertriever 17 device which was used for an acute ischemic stroke.After successful removal of a thrombus from the aca, the device was directed into the proximal mca segment.When trying to deflate the device, no reaction was detected.When removal was attempted, resistance was met.Ultimately the device was successfully removed, however a dissection was subsequently observed.As a result, hemorrhaging was noted in the area of treatment and the patient ultimately expired.

• Brand Name: TIGERTRIEVER 17
• Common Device Name: TIGERTRIEVER 17
• Manufacturer (Section D): RAPID MEDICAL LTD.; pob 337; carmel building; israel 20692 05; IS 2069205
• MDR Report Key: 18238546
• Report Number: 3015531723-2023-00009
• Device Sequence Number: 15187464
• Product Code: NRY
• UDI-Device Identifier: 07290015107273
• UDI-Public: (01)07290015107273(17)240531(10)211223TS01
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/30/2023
• Report Date (Section F): 11/30/2023

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: 05/31/2024
• Device Model Number: TIGERTRIEVER 17
• Device Catalogue Number: TRPP7166
• Device Lot Number: 211223TS01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/29/2023
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/21/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/30/2023
• 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: Death
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/30/2023