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

Model Number	4MAXCKIT
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2021
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: 3005168196-2021-01890.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the posterior cerebral artery using a penumbra system 3max reperfusion catheter (3maxc) and penumbra system max 4 reperfusion catheter (4maxc).During the procedure, it was reported that a 3maxc and a 4maxc became stretched.It is unknown how the procedure was completed or if there was any adverse effect to the patient.

• 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: 12365964
• Report Number: 3005168196-2021-01889
• Device Sequence Number: 19826973
• Product Code: NRY
• UDI-Device Identifier: 00814548016740
• UDI-Public: 00814548016740
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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
• Report Date (Section B): 08/25/2021
• 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: 03/21/2024
• Device Model Number: 4MAXCKIT
• Device Catalogue Number: 4MAXCKIT
• Device Lot Number: F104743
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 08/25/2021
• 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