MAUDE Adverse Event Report: RAPID MEDICAL LTD. TIGERTRIEVER

Model Number	TRPP7155
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation of the returned device revealed that the device was fractured at the shaft-to-handle connection.This observation confirmed the event description most likely occurred due to excessive forces applied during retrieval.The mesh was deployed inside a severely calcified lesion.Tthis might be the reason that the initial resistance was felt.The resistance and the excessive forces applied as a result might have caused the disconnection between the cable and the connector and ultimately to the core wire tear.The technical investigation of the returned subject device demonstrated that it was properly assembled and manufactured.In addition, lot history review revealed no anomaly relating to the reported event, and no other similar product experience report was received for this lot.
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
• Manufacturer (Section D): RAPID MEDICAL LTD.; po box 337; carmel building; yokneam, israel 20692 05; IS 2069205
• MDR Report Key: 17009819
• Report Number: 3015531723-2023-00217
• Device Sequence Number: 20750285
• 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
• 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): 05/25/2023
• Report Date (Section F): 05/02/2023

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: 08/31/2024
• Device Model Number: TRPP7155
• Device Catalogue Number: TRPP7155
• Device Lot Number: 220401TR02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/29/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/29/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2023
• 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: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/02/2023