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

Model Number	TRPP7144
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
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.
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.

• Brand Name: TIGERTRIEVER REVASCULAZATION DEVICE
• Common Device Name: TIGERTRIEVER 13
• Manufacturer (Section D): RAPID MEDICAL INC; 445 s. kimball ave. suite 140; southlake, tx 76092 ; IS 76092
• MDR Report Key: 20555142
• Report Number: 3015531723-2024-00003
• Device Sequence Number: 18364212
• 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
• 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): 10/29/2024
• Report Date (Section F): 10/29/2024

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: 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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/30/2024
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2024
• 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: Disability
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/29/2024