MAUDE Adverse Event Report: RAPID MEDICAL LTD TIGERTRIEVER REVASCULAZATION DEVICE; TIGERTRIEVER 17

Model Number	TIGERTRIEVER 17
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	11/18/2023
Type of Reportable Event	Death
Additional 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 when released.Potential adverse events such as dissection and hemorrhage are included in the device labelling.Consequently, it was determined that the reported adverse event is anticipated complication.
Event or Problem 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 REVASCULAZATION DEVICE
• Common Device Name: TIGERTRIEVER 17
• Manufacturer (Section D): RAPID MEDICAL LTD; p.o.box 337; carmel building; yokneam, 20692 05; IS 2069205
• Manufacturer (Section G): RAPID MEDICAL LTD; 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: 18235612
• Report Number: 3009957947-2023-00009
• Device Sequence Number: 3227200
• Product Code: NRY
• UDI-Device Identifier: 07290015107273
• UDI-Public: (01)07290015107273(17)240531(10)211223TS01
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K203592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/29/2023

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Death
• Patient Sex: Unknown