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	12/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned 3maxc confirmed a distal shaft fracture.Evalution revealed stretching at the fractured location.This indicated that the device was stretched prior to fracturing.If the device is manipulated against resistance, damages 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 proximal shaft and ovalization on the distal shaft.This damage was likely incidental to the complaint.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 internal carotid artery (ica) using a penumbra system red72 reperfusion catheter (red72), penumbra system 3max reperfusion catheter (3maxc), and guidewire.It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician was advancing the 3maxc over a guidewire through red72 and up the ica.Subsequently, when the 3maxc reached the distal middle cerebral artery (mca), the physician noticed under fluoroscopy that the distal end of the 3maxc was broken.Therefore, the red72 was removed containing the broken 3maxc and guidewire.It was also reported that the red72 was bent at the proximal end close to the hub.The 3maxc and red72 was not used for the remainder of the procedure.The physician then attempted to use a new 3maxc and a new red72; however, the physician was unable to track the red72 up to the target location using the 3maxc.Therefore, the physician decided to remove the 3maxc.There was no damage noted on the 3maxc.The procedure was completed using a new non-penumbra catheter, same red72, and the same guidewire to achieve thrombolysis in cerebral infarction (tici) 3.There was no report of an adverse effect to the patient.

• 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: 16215492
• Report Number: 3005168196-2023-00038
• Device Sequence Number: 12243489
• Product Code: NRY
• UDI-Device Identifier: 00814548019956
• UDI-Public: 814548019956
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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
• Report Date (Section B): 01/20/2023
• 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: 10/04/2025
• Device Catalogue Number: 3MAXC
• Device Lot Number: F00003435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2023
• 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: 12/26/2022
• Initial Report FDA Received Date: 01/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2022
• 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: 74 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005