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

Model Number	4MAXC
Medical Device Problem Codes	Fracture (1260); Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2021
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 m1 segment of 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, the physician advanced the 4maxc into the m1 segment of the mca and completed a pass that removed the thrombus.Afterwards, the physician attempted to advance the 4maxc into the m2 segment of the mca to perform a second pass and experienced resistance.Subsequently, the 4maxc would not advance into the m2 segment of the mca.Therefore, the physician decided to remove the 4maxc.Upon removal, it was noticed that the distal end of the 4maxc was fractured.The procedure was completed by administering alteplase to the patient since the hospital did not have another 4maxc to use.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed on the initial mfr report and is being included on this follow-up # 02 mfr report:.1.Section h.Box 6.Device code 3 h3 other text : placeholder.
Additional Manufacturer Narrative
Evaluation of the returned 4maxc confirmed that the catheter was fractured on its midshaft.This damage typically occurs due to forceful retraction against resistance.The root cause of the reported resistance could not be determined.Further evaluation revealed an ovalization and a kink.This damage was incidental to the reported complaint.Penumbra catheters are visually 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.H3 other text : placeholder.

• Brand Name: PENUMBRA SYSTEM 4MAX 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: 11693639
• Report Number: 3005168196-2021-00790
• Device Sequence Number: 3437352
• Product Code: NRY
• UDI-Device Identifier: 00814548012414
• UDI-Public: 00814548012414
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/16/2022
• 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: 10/20/2022
• Device Model Number: 4MAXC
• Device Catalogue Number: 4MAXC
• Device Lot Number: F93773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 08/23/2021; 01/14/2005
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 08/25/2021; 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2019
• 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: 25 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005