MAUDE Adverse Event Report: PENUMBRA, INC. SENDIT DELIVERY DEVICE; NRY

Catalog Number RED72SDKIT

Device Problems Fracture (1260); Physical Resistance/Sticking (4012)

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

Event Date 10/17/2023

Event Type  malfunction  

Event Description

The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system red 72 reperfusion catheter (red72), a sendit delivery device (sendit), a neuron max 6f 088 long sheath (neuron max) and a guidewire.During the procedure, the physician advanced the red72 and sendit to the face of the clot in the target vessel; however, while attempting to remove the sendit from the red72, the physician experienced resistance.The physician was able to remove the sendit with some force.Upon removal, it was noticed that the distal end of the sendit was not connected.Therefore, the red72 was removed and the distal end of the sendit was found inside the red72.The procedure was completed using a velocity delivery microcatheter (velocity), a new red72 and the same neuron max.There was no report of an adverse effect to the patient.

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.

Manufacturer Narrative

Evaluation of the returned sendit confirmed that the device was fractured.The complaint indicated that resistance was experienced during removal of the device out of the red72.If the sendit device is retracted against resistance, damage such as stretching, and fracture may occur.The red72 was not returned for evaluation.Therefore, the root cause of resistance could not be determined.Further evaluation revealed a kink distal to the hub.This damage was incidental to the reported complaint and may have occurred during packaging of the device for return to penumbra.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.H3 other text : placeholder.

• Brand Name: SENDIT DELIVERY DEVICE
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 18114453
• MDR Text Key: 328134742
• Report Number: 3005168196-2023-00499
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948025943
• UDI-Public: 815948025943
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RED72SDKIT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 10/18/2023
• Initial Date FDA Received: 11/10/2023
• Supplement Dates Manufacturer Received: 11/06/2023
• Supplement Dates FDA Received: 11/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 54 YR
• Patient Sex: Female