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

Model Number	4MAXCKIT
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
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 in the in the middle cerebral artery (mca) using a penumbra system 4max reperfusion catheter (4maxc) and a neuron max 6f 088 long sheath (neuron max).During the procedure, while inserting a 4maxc into the neuron max, the physician experienced resistance and decided to remove the 4maxc.Upon removal, it was noticed that approximately twenty centimeters from the distal end of the 4maxc was broken.The procedure was completed using a new 4maxc and the same neuron max.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 yield marks near the fracture.This indicates that the device likely kinked prior to fracturing.If the 4maxc is forcefully manipulated against resistance, damage such as a kink and subsequent fracture may occur.The root cause of resistance could not be determined.Further evaluation of the 4maxc revealed kinks along the proximal shaft.This damage was likely incidental to the reported 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 4MAX REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11768095
• Report Number: 3005168196-2021-00932
• Device Sequence Number: 14397305
• Product Code: NRY
• UDI-Device Identifier: 00814548016740
• UDI-Public: 00814548016740
• Combination Product (Y/N): Y
• Initial Reporter Country: PL
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2021
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/04/2023
• Device Model Number: 4MAXCKIT
• Device Catalogue Number: 4MAXCKIT
• Device Lot Number: F99315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 80
• Date Report Sent to FDA: 01/01/2005