MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER; NRY

Model Number	RED72-A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned red72 revealed multiple consecutive kinks along the distal shaft.This damage is likely the reported ¿accordion¿ on the distal third of the catheter and confirms the reported complaint.The issue with the red72 was discovered after the third pass of using a stent retrieve with the catheter; therefore, the probable cause of this damage may be due to forceful manipulation of the stent retriever within the red72.Penumbra catheters 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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left middle cerebral artery (mca) using a penumbra system red 72 reperfusion catheter (red72), a velocity delivery microcatheter (velocity), a non-penumbra stent retriever, and a neuron max 6f 088 long sheath (neuron max).During the procedure, the physician made the first pass using the adapt technique with a red72.The physician made the second and third pass using a stent retriever with the red72.Subsequently, the stent retriever was retracted back into the red72, the physician then removed both the stent retriever and red72 as a unit and noticed the distal third of the red72 to be accordioned on the back table.Therefore, the red72 was not used for the remainder of the procedure.The procedure was completed using a penumbra system ace 68 reperfusion catheter (ace68) with the same velocity, stent retriever, and neuron max.It was reported that the physician was unable to achieve reperfusion.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12598762
• Report Number: 3005168196-2021-02218
• Device Sequence Number: 11631291
• Product Code: NRY
• UDI-Device Identifier: 00815948023918
• UDI-Public: 00815948023918
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K211654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/07/2021
• 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 Expiration Date: 07/08/2024
• Device Model Number: RED72-A
• Device Catalogue Number: RED72
• Device Lot Number: F107645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• 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: 09/12/2021
• Initial Report FDA Received Date: 10/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005