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	12/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left middle cerebral artery (mca) using a penumbra system 3max reperfusion catheter (3maxc), a penumbra system red 68 reperfusion catheter (red68) and a benchmark bmx96 access system (bmx96).During the procedure, the physician placed the red68 through the bmx96 in the target location using the 3maxc.Subsequently, the 3maxc was removed.Upon removal, the distal end of the 3maxc was noticed to be broken.The physician then noticed under fluoroscopy that the distal end of the 3maxc was in the patient.At this point a new 3maxc was opened and advanced through the red68 to aspirate the broken distal end of the first 3maxc, however, it was unsuccessful.Therefore, the physician decided to remove the second 3maxc.While attempting to retract the second 3maxc, the 3maxc became stretched; however, the physician was able to remove it.The physician then decided to use a snare device and removed the distal end of the first 3maxc.After removing the 3maxc, the physician decided to use a velocity delivery microcatheter (velocity) with a penumbra system red 62 reperfusion catheter (red62).While attempting to remove the velocity from the packaging hoop, the velocity fractured at the mid-shaft.Therefore, the velocity was not used.The procedure was completed using a new velocity, a red62 and the same bmx96.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the first returned 3maxc confirmed that the catheter was fractured.Evaluation revealed that the catheter fractured on the stretched region indicating the device was stretched prior to fracturing.Stretching typically occurs as a result of retraction against resistance.The root cause of the resistance experienced during the procedure could not be determined.If a stretched device is further retracted against resistance, it may become fractured.Further evaluation revealed kinks along the catheter shaft.This damage was likely incidental and may have occurred during packaging for return.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: 16080815
• Report Number: 3005168196-2022-00604
• Device Sequence Number: 6275461
• Product Code: NRY
• UDI-Device Identifier: 00814548019956
• UDI-Public: 814548019956
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 12/30/2022
• 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: 05/15/2025
• Device Catalogue Number: 3MAXC
• Device Lot Number: F00000783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2022
• 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: 12/06/2022
• Initial Report FDA Received Date: 12/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2022
• 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: 34 YR
• Patient Sex: Female
• Patient Weight: 113 KG
• Date Report Sent to FDA: 01/01/2005