MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER; NRY

Catalog Number	RED62S
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2023
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 right m1 and m2 segments of the middle cerebral artery (mca) using a penumbra system red 62 reperfusion catheter (red62), a balloon catheter, and a guidewire.It should be noted that the patient''s anatomy was tortuous.During the procedure, the physician completed three passes in the target location using the red62.After the third pass, the physician injected contrast through the red62 in order to check the thrombolysis in cerebral infarction (tici) score and noticed under fluoroscopy that the red62 was expanded.Therefore, the red62 was removed.The physician opened a penumbra system ace 68 reperfusion catheter (ace68) and found that the ace68 was ovalized at the distal length.The physician still attempted to introduce the ace68 through the same balloon catheter without success.Therefore, the ace68 was removed.The procedure was completed using the same balloon catheter and a non-penumbra revascularization device.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report 3005168196-2024-00001.Section b.Box 5.Describe event or problem.Evaluation of the returned red62 revealed stretching on the distal end of the catheter.It was also confirmed that the damage region expanded when flushed during evaluation.The root cause of the damage could not be determined.However, if a damaged catheter is flushed, the damaged region may expand.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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right m1 and m2 segments of the middle cerebral artery (mca) using a penumbra system red 62 reperfusion catheter (red62), a balloon catheter, and a guidewire.It should be noted that the patient's anatomy was tortuous.During the procedure, the physician completed three passes in the target location using the red62.After the third pass, the physician injected contrast through the red62 and noticed under fluoroscopy that the red62 was expanded.Therefore, the red62 was removed.The procedure was completed using the same balloon catheter and a non-penumbra revascularization device.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM RED 62 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: 18428456
• Report Number: 3005168196-2024-00001
• Device Sequence Number: 7731543
• Product Code: NRY
• UDI-Device Identifier: 00815948023475
• UDI-Public: 815948023475
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K203440
• 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
• Report Date (Section B): 01/25/2024
• 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: 06/08/2026
• Device Catalogue Number: RED62S
• Device Lot Number: F00007100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2023
• Is the Reporter a Health Professional?: Yes
• 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: 12/05/2023
• Supplement Date Received by Manufacturer: 12/29/2023
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2023
• 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: 82 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005