MAUDE Adverse Event Report: RAPID MEDICAL LTD TIGERTRIEVER REVASCULAZATION DEVICE; TIGERTRIEVER 13

Model Number	TRPP7144
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Stroke/CVA (1770)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation of the returned device confirmed that the device distal portion (distal to the connector: cable mesh and tip) was missing and appeared to be detached from the connector.Other than that, the handle structure and mechanism were found to be proper.A review of the device history record (dhr) confirms no deficiencies during the manufacturing or inspection of this batch.The device was manufactured according to all established quality standards and regulatory requirements.Prior to release, the device underwent thorough quality control inspections and testing, including functional assessments designed to verify its performance and integrity.All components of the device, including the handle, mesh, and cable, met the required specifications and passed these inspections without any indication of defects.In conclusion, based on the investigation and documentation available, the tigertriever 13 device was fully compliant with all quality and performance requirements at the time of release, and there is no evidence of a manufacturing defect contributing to the reported event.
Event or Problem Description
During the procedure, the tigertriever 13 was delivered to the inferior right m2 branch using a zoom 88 and a 35 mc.Proximal tortuosity was observed in the ica segment.The device was unsheathed and fully closed prior to retrieval, followed by aspiration.Additional sedation was administered, and a second retrieval attempt was made.During this attempt, the patient unexpectedly moved, causing a sudden loss of tension on the device.Despite the change in tension, the handle was further retracted.Upon removal of the handle and hypotube, it was noted that the mesh and cable remained inside the patient's body.

• Brand Name: TIGERTRIEVER REVASCULAZATION DEVICE
• Common Device Name: TIGERTRIEVER 13
• Manufacturer (Section D): RAPID MEDICAL LTD; p.o.box 337; carmel building; yokneam, 20692 05; IS 2069205
• Manufacturer (Section G): RAPID MEDICAL; 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: 20555068
• Report Number: 3009957947-2024-00003
• Device Sequence Number: 13010917
• Product Code: NRY
• UDI-Device Identifier: 07290015107303
• UDI-Public: (01)07290015107303(17)260331(10)231046TL01
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: 03/31/2026
• Device Model Number: TRPP7144
• Device Catalogue Number: TRPP7144
• Device Lot Number: 231046TL01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (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: Disability
• Patient Sex: Unknown