MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM MAX 4 REPERFUSION CATHETER; NRY

Model Number	4MAXC
Medical Device Problem Codes	Fracture (1260); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2021
Type of Reportable Event	Serious Injury
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 in the m2 segment of the middle cerebral artery (mca) using a penumbra system 4max reperfusion catheter (4maxc), non-penumbra sheath and microcatheter.It was reported that patient had a very tortuous anatomy.During the procedure, the physician tracked the 4maxc to the clot and started aspiration.When the physician attempted to retract the 4maxc during the first pass, they experienced resistance.Upon removal of the 4maxc it was reported that it broke and the distal end of the 4maxc remained in the patient.The physician then used a snare device to remove the broken 4maxc.The procedure ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned 4maxc confirmed a fracture on the mid-shaft.Further evaluation revealed that the internal coil winds were unraveled, and bends were present on both sides of the fracture.If the device is forcefully retracted against resistance, damage such as a fracture may occur.The unraveled coil winds were likely incidental to the complaint and likely occurred during removal of the device from the procedure.The anatomy was reported to be very tortuous.This may have contributed to the resistance experienced during the procedure.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 MAX 4 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12309366
• Report Number: 3005168196-2021-01794
• Device Sequence Number: 19750516
• Product Code: NRY
• UDI-Device Identifier: 00814548012414
• UDI-Public: 00814548012414
• Combination Product (Y/N): Y
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2021
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/17/2023
• Device Model Number: 4MAXC
• Device Catalogue Number: 4MAXC
• Device Lot Number: F102053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 08/11/2021
• Supplement Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Date Report Sent to FDA: 01/01/2005