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

Model Number	4MAXC
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 3005168196-2021-01063.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left m2 segment of the middle cerebral artery (mca) using a velocity delivery microcatheter (velocity), a penumbra system 4max reperfusion catheter (4maxc), and a guidewire.It was noted that the patient¿s anatomy was very tortuous.During the procedure, while co-axially advancing the 4maxc with the velocity, the physician experienced resistance and decided to retract the velocity.While retracting the velocity, the physician noticed under fluoroscopy that the tip of the velocity was not moving.The physician then realized that the velocity broke at the proximal one third within the 4maxc; therefore, the physician advanced a microwire through the 4maxc and twisted the microwire several times to successfully capture and remove the broken piece of the velocity.Subsequently, the 4maxc was also removed.The procedure was completed using a non-penumbra microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #xx mfr report: 1.Section g.Box 4.Date received by manufacturer (mm/dd/yyyy) 2.Section h.Box 5.Labeled for single use? this report is associated with mfr report number: 1.3005168196-2021-01063.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
• MDR Report Key: 11837661
• Report Number: 3005168196-2021-01064
• Device Sequence Number: 2989990
• Product Code: NRY
• UDI-Device Identifier: 00814548012414
• UDI-Public: 00814548012414
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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): 10/01/2021
• 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: 09/22/2023
• Device Model Number: 4MAXC
• Device Catalogue Number: 4MAXC
• Device Lot Number: F100429
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 10/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Date Report Sent to FDA: 01/01/2005