MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER; NRY

Catalog Number	5MAXACE068KIT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2024
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.Placeholder.
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 ace 68 reperfusion catheter (ace68), a penumbra engine (engine), a non-penumbra sheath, a non-penumbra intermediate catheter, and a guidewire.It was noted that the patient''s anatomy was tortuous.During the procedure, the physician advanced the ace68 over the guidewire to the occlusion site and initiated aspiration using the engine and a syringe attached to the sheath.After successfully completing one pass, the physician attempted to retract the ace68 but noticed a curve in the distal end of the sheath.The physician then proceeded to retract the ace68; however, it was observed that the radio marker of the ace68 was not responding to the retraction and remained in place.Upon removal, it was noted that the distal length of the ace68 had unraveled and fractured approximately 10 to 15 centimeters from the distal end.It was reported that the distal fragment of the ace68 was in the carotid artery in front of the distal end of the intermediate catheter.The physician then connected the engine, activated the aspiration directly to the intermediate catheter, and successfully extracted the distal fragment.The procedure ended at this point.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM ACE 68 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: 19736291
• Report Number: 3005168196-2024-00249
• Device Sequence Number: 20603170
• Product Code: NRY
• UDI-Device Identifier: 00815948022850
• UDI-Public: 00815948022850
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K161640
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/12/2024
• 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 Catalogue Number: 5MAXACE068KIT
• Device Lot Number: H00004351
• Was Device Available for Evaluation?: No
• 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: 06/18/2024
• Initial Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2024
• 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: 75 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005