MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER; NRY

Catalog Number	RED68
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.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 left middle cerebral artery (mca) using a penumbra system red 68 reperfusion catheter (red68) and a non-penumbra sheath.During the procedure, the physician placed the sheath in the patient using right radial access.While advancing the red68 through the sheath, the physician experienced resistance and subsequently, the physician broke the red68 into two pieces at approximately the mid-shaft.Therefore, the physician used a snare device to successfully remove the broken red68.The procedure was completed using the same sheath, another catheter, and a stent retriever.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: 3005168196-2022-00549.Section b.Box 5.Describe event or problem.Evaluation of the returned red68 confirmed that the catheter was fractured.If the red68 is advanced against resistance during use, damage such as a fracture may occur.Further evaluation revealed ovalization distal to the fractured location and distal tip, and kinks on the distal fractured segment.Based on the reported complaint, the red 68 was advanced through the sheath without a guidewire.Advancement of the red68 without a guidewire may have contributed to the resistance and difficulty experienced while using the device.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 68 reperfusion catheter (red68) and a non-penumbra sheath.During the procedure, the physician placed the sheath in the patient using right radial access.While advancing the red68 through the sheath, the physician experienced resistance and subsequently, broke the red68 into two pieces at the mid-shaft area.Therefore, the physician used a snare device to successfully remove the broken red68.The procedure was completed using the same sheath, another catheter, and a stent retriever.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM RED 68 REPERFUSION CATHETER
• 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: 15840083
• Report Number: 3005168196-2022-00549
• Device Sequence Number: 5846518
• Product Code: NRY
• UDI-Device Identifier: 00815948024090
• UDI-Public: 815948024090
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K211411
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2023
• 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: 02/13/2025
• Device Catalogue Number: RED68
• Device Lot Number: C00001251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/03/2022
• Supplement Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2022
• 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: 79 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005