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

Model Number	5MAXACE132-A
Medical Device Problem Codes	Stretched (1601); Material Deformation (2976); Suction Failure (4039)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.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).It was noted that the patient anatomy was tortuous.During the procedure, the physician completed two passes using the ace60.Then, during the third pass, it was noticed that no thrombus was being aspirated out after some time; therefore, the physician decided to remove the ace60.After the removal of the ace60, it was noticed that there was a 5 to 10 centimeters ovalization from the back of the metal ring at the head end to the near end of the ace60.The procedure was completed using a new ace60.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the ace60 was stretched and ovalized approximately 111.0 cm ¿ 138.0 cm from the hub.Coagulated blood was observed within the damaged region.The total length was measured to be approximately 144.0 cm.The marker band was ovalized at the catheter distal tip approximately 144.0 cm from the hub.Conclusions: evaluation of the returned ace60 confirmed that the device was ovalized and stretched on its distal shaft.This damage is typically a result of forcefully retracting the device against resistance.This damage likely contributed to the reported difficulty in aspiration during the procedure.The reported tortuous patient anatomy may have contributed to the resistance while retracting the device.Further evaluation of the device revealed that the marker band was ovalized at the catheter distal tip and coagulated blood within the damaged catheter lumen.Based on the image provided by the customer, this damage was likely incidental to the complaint.During functional testing, the ace68 was unable to advance into a demonstration neuron max due to the marker band ovalization.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.
Additional Manufacturer Narrative
Please note that the following sections have been updated based on additional information received by the distributor on 02/22/2021: section b.Box 5.Describe event or problem; section e.Box 1.Title; section e.Box 1.First name; section e.Box 1.Last name; section e.Box 3.Occupation; section h.Box 6.Device code 3.
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 sheath.During the procedure, aspiration was initiated; however, thrombus could not be removed.After two attempts.The physician removed the ace60 from the patient.Upon removal of the ace60, it was noted that it was ovalized and stretched.The procedure was completed using a new ace60 and the same sheath.There was no report of an adverse effect to the patient.

• 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: 10196980
• Report Number: 3005168196-2020-00818
• Device Sequence Number: 2973854
• 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,Followup
• Report Date (Section B): 05/31/2020
• 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: 09/19/2021
• Device Model Number: 5MAXACE132-A
• Device Catalogue Number: 5MAXACE132
• Device Lot Number: F85961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/31/2020
• Supplement Date Received by Manufacturer: 12/17/2020; 02/22/2021
• Initial Report FDA Received Date: 06/25/2020
• Supplement Report FDA Received Date: 12/23/2020; 03/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Date Report Sent to FDA: 01/01/2005