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

Catalog Number	RED72SDKIT
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2024
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right 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 (0.014).It was reported that the patient¿s anatomy was tortuous with a significant turn at the internal carotid artery (ica) terminus and mca.During the procedure, the physician experienced resistance while advancing the red72 and sendit past the ica terminus.The red72 and the sendit where advanced to the target location, the physician then experienced resistance again while removing the guidewire and the sendit.The physician continued to pull the sendit from the red72 and it was reported there was a release of pressure.Upon removal of the sendit, the physician noticed that ten centimeters of the sendit distal length was missing.Aspiration was initiated on the red72 to secure the fractured segment of the sendit under fluoroscopy.The red72 containing the fractured segment of the sendit was removed from the patient.The fractured segment of the sendit was then flushed out of the red72 on the back table.It was reported that the red72 was noticed to be kinked at the distal end.Therefore, the red72 was not used for the remainder of the procedure.The procedure was completed using a penumbra system red 68 reperfusion catheter (red68), a penumbra system red 43 reperfusion catheter (red43), the same neuron max, and another guidewire (0.035).Thrombolysis in cerebral infarction (tici) 3 was achieved.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned sendit confirmed a fracture on the distal end.If the device is retracted against resistance, damage such as a fracture may occur.The kinks and ovalizations on the distal end of the retuned red72 likely contributed to resistance during retraction of the sendit during the procedure.Penumbra devices are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: SENDIT DELIVERY DEVICE
• Common Device Name: 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: 20177177
• Report Number: 3005168196-2024-00307
• Device Sequence Number: 15627206
• Product Code: NRY
• UDI-Device Identifier: 00815948025943
• UDI-Public: 00815948025943
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K211654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2024
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Catalogue Number: RED72SDKIT
• Device Lot Number: F00012167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Age: 59 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005