MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER; NRY

Model Number	5MAXACE132-A
Medical Device Problem Codes	Material Deformation (2976); Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2020
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 m1 segment of the middle cerebral artery (mca) using a penumbra system ace 60 reperfusion catheter (ace60) and a non-penumbra long sheath.It was noted that the patient anatomy was tortuous.During the procedure, the physician experienced resistance in the ophthalmic artery while using an ace60.However, the physician was able to place the ace60 into the target location.Next, the physician initiated aspiration but after 3 and a half minutes under aspiration, it was noticed that no thrombus was retrieved and the physician decided to remove the ace60.Upon removal, it was noticed that the ace60 was deformed at approximately seven centimeters from the distal end.The procedure was completed using a stent retriever and the same long sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ace60 revealed kinks and ovalizations on its distal shaft.If the device is advanced through a tortuous patient anatomy, resistance may be encountered.If the device is forcefully advanced against the resistance, damage such as kinks and ovalizations may occur.This damage likely contributed to the difficulty aspiration during the procedure.Further evaluation of the device revealed a proximal shaft fracture, and a non-penumbra hub was attached to the distal fractured segment.This damage was not identified in the reported complaint.It is unknown if the device was used for aspiration with the non-penumbra hub.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.H3 other text : placeholder.

• Brand Name: PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12242591
• Report Number: 3005168196-2021-01678
• Device Sequence Number: 14355572
• Product Code: NRY
• UDI-Device Identifier: 00814548017426
• UDI-Public: 00814548017426
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2021
• 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: 04/16/2022
• Device Model Number: 5MAXACE132-A
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F89655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 07/28/2021
• Supplement Report FDA Received Date: 10/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Date Report Sent to FDA: 01/01/2005