MAUDE Adverse Event Report: RAPID MADICAL LTD. TIGERTRIEVER; TIGERTRIEVER REVASCULAZATION DEVICE

Model Number	TRPP7155
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was diagnosed with severe calcified lesion in the left carotid and the physician was unable to pass the lesion with his sheath to treat a more distal stroke.Aspiration with a zoom catheter was tried first.When aspiration failed, the decision was made to cross the lesion with a velocity microcatheter and tigertriever 21.Tiger was successfully expanded.When it was time to pull the device out, the physician experienced resistance and fully collapsed the device.There was still resistance in the system and the device broke off at the proximal connection between the hypotube shaft and the mesh.The physician was able to aspirate the stent into the sheath using a 60cc syringe and no harm was done to the patient and no part of the stent was left in the patient.

• Brand Name: TIGERTRIEVER
• Common Device Name: TIGERTRIEVER REVASCULAZATION DEVICE
• Manufacturer (Section D): RAPID MADICAL LTD.; pob 337; yokneam, 20692 05; IS 2069205
• Manufacturer (Section G): RAPID-MEDICAL LTD; pob 337; yokneam, 20692 05; IS 2069205
• Manufacturer Contact: ronen eckhouse ; pob 337; yokneam, 20692-05 ; IS 2069205
• MDR Report Key: 16843653
• Report Number: 3009957947-2023-00008
• Device Sequence Number: 6823167
• Product Code: NRY
• UDI-Device Identifier: 07290015107266
• UDI-Public: (01)07290015107266(17)240831(10)220401TR02
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K220808
• 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

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: 08/31/2024
• Device Model Number: TRPP7155
• Device Catalogue Number: TRPP7155
• Device Lot Number: 220401TR02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Hospitalization
• Patient Sex: Unknown