MAUDE Adverse Event Report: RAPID MEDICAL LTD. TIGERTRIEVER 17

Model Number TIGERTRIEVER 17

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 11/18/2023

Event Type  Death  

Manufacturer Narrative

Additional procedural details were obtained from the reporting physician on a teleconference that was held on november 27th, 2023.It was pointed out by the physician that it seems that the device got caught on an undetectable piece of calcium which prevented proper deflation and retrieval.The device was discarded after use and therefore not available for return and investigation, however it was mentioned by the physician that the device was intact and fully deflated when removed from the patient.The physician also mentioned during the call that the patient was pretreated with aggrastat, which could have resulted in an excess bleeding.Based on the results of the investigation, dhr review, and procedure details, there is no indication that the device, labeling or packaging failed to meet its specifications.

Event Description

Rapid medical received a report regarding the tigertriever 17 device which was used for an acute ischemic stroke.After successful removal of a thrombus from the aca, the device was directed into the proximal mca segment.When trying to deflate the device, no reaction was detected.When removal was attempted, resistance was met.Ultimately the device was successfully removed, however a dissection was subsequently observed.As a result, hemorrhaging was noted in the area of treatment and the patient ultimately expired.

• Brand Name: TIGERTRIEVER 17
• Type of Device: TIGERTRIEVER 17
• Manufacturer (Section D): RAPID MEDICAL LTD.; pob 337; carmel building; israel 20692 05; IS 2069205
• MDR Report Key: 18238546
• MDR Text Key: 329382958
• Report Number: 3015531723-2023-00009
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 07290015107273
• UDI-Public: (01)07290015107273(17)240531(10)211223TS01
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/30/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: TIGERTRIEVER 17
• Device Catalogue Number: TRPP7166
• Device Lot Number: 211223TS01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/30/2023
• Distributor Facility Aware Date: 11/29/2023
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/21/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death