MAUDE Adverse Event Report: RAPID MEDICAL LTD TIGERTRIEVER; TIGERTRIEVER 17 REVASCULARIZATION DEVICE

Model Number	TRPP7166
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	05/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by a healthcare professional that a patient underwent mechanical thrombectomy of right mca (2nd division) occlusion with a tigertriever 17 and experienced a subarachnoid hemorrhage (sah) post-procedure.The patient had a previous stroke in this area.Previous treatment approximately 2 days prior.A total of six passes were made, 1st and 6th passes were combination tigertriever 17 and aspiration.Passes 2-5 were direct aspiration alone.There was no allegation against the tigertriever 17 device.No additional treatment or intervention was reported.Tici 2a was achieved.The healthcare professional determined the event was probably procedure related and may be related to the tigertriever 17 device.

• Brand Name: TIGERTRIEVER
• Common Device Name: TIGERTRIEVER 17 REVASCULARIZATION DEVICE
• Manufacturer (Section D): RAPID MEDICAL LTD; po box 337; carmel building; yokneam, israel 20692 05; IS 2069205
• MDR Report Key: 14711850
• Report Number: 3015531723-2022-00011
• Device Sequence Number: 12128453
• Product Code: NRY
• UDI-Device Identifier: 07290015107273
• UDI-Public: (01)07290015107273(17)240630(10)220114TS01
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/16/2022
• Report Date (Section F): 06/16/2022

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 Model Number: TRPP7166
• Device Catalogue Number: TRPP7166
• Device Lot Number: 220114TS01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/16/2022
• Device Age: 6 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2022
• 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: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/16/2022