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

Model Number	TRPP7166
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided and the known risks associated with mechanical thrombectomy in ischemic stroke, including hemorrhagic transformation, the event is considered a known potential complication.No device malfunction was reported.
Event or Problem Description
A 49-year-old female in the cognitive post-market study presented with a right m1 occlusion and underwent thrombectomy using the tigertriever 17 with aspiration, achieving tici 2c after multiple passes.Post-procedure imaging revealed a subarachnoid hemorrhage, which was promptly managed without further complications.The patient recovered well (nihss 0 at 24h) and was discharged for rehabilitation.

• Brand Name: TIGERTRIEVER REVASCULARIZATION DEVICE
• Common Device Name: TIGERTRIEVER 17
• Manufacturer (Section D): RAPID MEDICAL LTD; p.o.box 337; carmel building; yokneam, 20692 05; IS 2069205
• Manufacturer (Section G): RAPID MEDICAL LTD; p.o.box 337; carmel building; yokneam, 20692 05; IS 2069205
• Manufacturer Contact: ina gutman ; p.o.box 337; carmel building; yokneam, 20692-05 ; IS 2069205
• MDR Report Key: 21966076
• Report Number: 3009957947-2025-00002
• Device Sequence Number: 12884795
• Product Code: NRY
• UDI-Device Identifier: 07290015107273
• UDI-Public: (01)07290015107273(17)270228(10)240943TS01
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K203592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/06/2025

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
• Device Model Number: TRPP7166
• Device Catalogue Number: TRPP7166
• Device Lot Number: 240943TS01
• 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: Not provided
• Initial Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown