MAUDE Adverse Event Report: RAPID MEDICAL LTD TIGERTRIEVER 17 REVASCULARIZATION DEVICE

Model Number TRPP7166

Device Problem Use of Device Problem (1670)

Patient Problems Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 12/03/2021

Event Type  Injury  

Event Description

A report from the field indicated that during mechanical thrombectomy of the m2 with the tigertriever 17 revascularization device, the patient experienced perforation and bleeding.The perforation occurred when the physician moved the device tip forward to achieve better positioning.A balloon was inflated to stop the bleeding.Hemostasis was achieved, and the procedure was completed without any problem or sequelae.

Manufacturer Narrative

Product analysis cannot be conducted as the product was not returned for analysis.In addition, there was no report of malfunction associated with the device.Vessel perforation is a possible adverse event associated with the use of the tigertriever 17 revascularization device in mechanical thrombectomy and is listed in the instructions for use (ifu).Based on the information provided, the manipulation of the device within the artery may have contributed to the reported perforation, as the physician advanced the unsheathed mesh distally.Repositioning of the device should be performed by re-sheathing the mesh, repositioning of the microcatheter, and then unsheathing the mesh again in the new position.

• Brand Name: TIGERTRIEVER 17 REVASCULARIZATION DEVICE
• Type of Device: TIGERTRIEVER 17
• Manufacturer (Section D): RAPID MEDICAL LTD; carmel building, p.o. box 337; yokneam, israel 20692 05; IS 2069205
• Manufacturer (Section G): RAPID-MEDICAL LTD; carmel building, pob 337; yokneam, 20692 05; IS 2069205
• Manufacturer Contact: orit yaniv ; carmel building, pob 337; yokneam, 20692-05 ; IS 2069205
• MDR Report Key: 13051860
• MDR Text Key: 282555584
• Report Number: 3009957947-2021-00009
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2021

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: 02/29/2024
• Device Model Number: TRPP7166
• Device Lot Number: 211003TS01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention