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

Model Number	3MAXCKIT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2020
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 posterior cerebral artery (pca) using a penumbra system 3max reperfusion catheter (3maxc), penumbra system ace 68 reperfusion catheter (ace68), penumbra engine (engine), and non-penumbra catheter.During the procedure, the physician advanced the distal tip of the 3maxc into the target vessel and started aspiration with the engine using adapt technique.Subsequently, 90 seconds after the blood inflow stopped, the physician attempted to remove the 3maxc.It appeared that the marker band of the 3maxc broke while retracting the 3maxc.Therefore, the physician turned off the engine and removed the 3maxc.Upon removal, the 3maxc was observed to be broken.It was reported that there was a break 55mm from the distal tip of the 3maxc on the back table.However, the physician confirmed that the marker band tip was not inside the patient.The physician continued the procedure using an ace68 with the same catheter, engine, and canister but was unable to achieve recanalization.The procedure ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the 3maxc was stretched approximately 123.0 cm - 170.0 cm from the hub.The catheter lumen was damaged, and the coil was exposed approximately 165.0 cm from the hub.The device was fractured approximately 170.0 cm from the hub.The distal segment of the fractured 3maxc was not returned for evaluation.Conclusions: evaluation of the returned 3maxc confirmed that the distal shaft was fractured and revealed that the device was stretched proximal to the fractured location.This indicated that the device was stretched prior to fracture.If the device is forcefully retracted against resistance, damage such as this may occur.Further evaluation of the 3maxc revealed that the catheter lumen was damaged, and the coil was exposed at the damaged location.Based on the reported complaint, this damage was occurred at the back table after the procedure; therefore, this damage was 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.

• Brand Name: PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10968794
• Report Number: 3005168196-2020-02210
• Device Sequence Number: 10990398
• Product Code: NRY
• UDI-Device Identifier: 00814548016757
• UDI-Public: 00814548016757
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2020
• 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: 01/16/2023
• Device Model Number: 3MAXCKIT
• Device Catalogue Number: 3MAXCKIT
• Device Lot Number: F95635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 01/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005