MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER; NRY

Catalog Number	3MAXC
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned 3maxc confirmed a fracture on the distal shaft.Evaluation revealed stretching at the fractured location.This indicated that the device was stretched prior to fracturing.If the 3maxc is retracted against resistance, damage such as stretching and subsequent fracture may occur.Based on the reported event, the root cause of the resistance could not be determined.Further evaluation revealed kinks on the distal fractured segment.This damage was incidental to the complaint.Some of the observed kinks may have occurred while snaring of the device.The root cause of the other kinks could not be determined.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.H3 other text : placeholder.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system 3max reperfusion catheter (3maxc), a penumbra system red 72 reperfusion catheter (red72) and a neuron max 6f 088 long sheath (neuron max).During the procedure, the 3maxc became stuck and the distal end of the 3maxc fractured within the red72.The physician then used a snare device with the red72 to retrieve the fractured segment of the 3maxc.The procedure was completed using a new 3maxc, a new red72 and the same neuron max.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: 3005168196-2023-00502.1.Section h.Box 10./11.Narrative/corrected data.Evaluation of the returned 3maxc confirmed a fracture on the distal shaft.Evaluation revealed stretching at the fractured location.This indicated that the device was stretched prior to fracturing.If the 3maxc is retracted against resistance, damage such as stretching and subsequent fracture may occur.Based on the reported event, the root cause of the resistance could not be determined.Further evaluation revealed kinks on the distal fractured segment.This damage was incidental to the complaint.Some of the observed kinks may have occurred while snaring of the device.The root cause of the other kinks could not be determined.Evaluation of the returned red72 could not confirm the reported difficulty advancing within its lumen.During evaluation the non-penumbra catheter and snare device returned inside the red72 lumen were removed without an issue, and a demonstration 3maxc was able to advance through the red72 without an issue.Further evaluation revealed kinks on the red72.This damage was likely incidental to the complaint.Some of the kinks on the red72 may have occurred during attempts to retrieve the fractured 3maxc distal segment using the snare 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.

• Brand Name: PENUMBRA SYSTEM 3MAX 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: 18097435
• Report Number: 3005168196-2023-00502
• Device Sequence Number: 17567100
• Product Code: NRY
• UDI-Device Identifier: 00814548019956
• UDI-Public: 814548019956
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K160449
• 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): 12/04/2023
• 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: 10/26/2025
• Device Catalogue Number: 3MAXC
• Device Lot Number: F00003835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2023
• 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: 10/13/2023
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2022
• 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: 78 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005