MAUDE Adverse Event Report: RAPID MEDICAL LTD TIGERTRIEVER REVESCULAZATION DEVICE; TIGERTRIEVER 21

Model Number TRPP7155

Device Problem Device Handling Problem (3265)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2023

Event Type  Injury  

Manufacturer Narrative

An evaluation of the returned device confirmed that the distal part of the device was separated from its proximal shaft, and the internal core wire was also fractured at the same area.The resistance felt by the physician while attempting to retrieve the device with clots inside into a microcatheter, and the excessive forces applied as a result, may have led to the disconnection between the shaft and the connector, ultimately causing the core wire to tear.The technical investigation of the returned subject device demonstrated that it was properly assembled and manufactured.A review of the device history record (dhr) records confirms that there were no issues with the assembly of the subject lot.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.

Event Description

It was reported that the tigertriever device was used in distal m1 occlusion along with rebar18 (mc) and sofia 6f (ac).According to the report from the field, when attempting the first retrieval, the physician felt resistance.He tried to pull the mc, with no success.The physician applied excessive force during retrieval which resulted in device breakage at the proximal connection between the hypotube shaft and the connector.The device was taken out of the patient using the aspiration catheter.Two clots were successfully removed with the tigertriever resulting in final tici- 2b/c.

• Brand Name: TIGERTRIEVER REVESCULAZATION DEVICE
• Type of Device: TIGERTRIEVER 21
• 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: 18343658
• MDR Text Key: 330666529
• Report Number: 3009957947-2023-00010
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 07290015107068
• UDI-Public: (01)07290015107068(17)251231(10)230757TR01
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K220808
• 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: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TRPP7155
• Device Catalogue Number: TRPP7155
• Device Lot Number: 230757TR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2023
• 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): Other