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

Catalog Number	3MAXC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2023
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 using a penumbra system 3max reperfusion catheter (3maxc), a penumbra system red62 reperfusion catheter (red62), and a guidewire.During the procedure, it was reported a 3maxc broke inside of a red62.Subsequently, the physician was unable to separate the 3maxc from the red62.It was also noted the guidewire was stuck in the 3maxc and red62.Therefore, the 3maxc, red62 and guidewire were removed together from the patient.No additional information regarding the completion of the procedure was provided.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned 3maxc confirmed that the catheter was fractured.Evaluation revealed that the 3maxc was stuck inside the red62 midshaft.The 3maxc is dimensionally incompatible to be advanced through a red 62 catheter.If the 3maxc is advanced through a red62, the device may become stuck, and resistance may be experienced during manipulation.If the device is manipulated against resistance during use, damage such as a kink and subsequent fracture may occur.Due to the returned damage the 3maxc was unable to functionally tested.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.

• 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: 16300318
• Report Number: 3005168196-2023-00064
• Device Sequence Number: 17688320
• Product Code: NRY
• UDI-Device Identifier: 00814548019956
• UDI-Public: 814548019956
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K160449
• 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): 03/09/2023
• 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: 12/30/2024
• Device Catalogue Number: 3MAXC
• Device Lot Number: F111834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2023
• 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: 01/06/2023
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2024
• 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: 12 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005