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

Model Number	5MAXACE068
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2020
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 middle cerebral artery (mca) using a penumbra system ace 68 reperfusion catheter (ace68) and neuron max 6f 088 long sheath (neuron max).During the procedure, the physician experienced resistance when tracking the ace68 to the target location.Therefore, the ace68 was removed and observed to be kinked at the distal tip.The procedure was completed using a new ace68 and the same neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the ace68 had kinks approximately 29.0, 53.5, 84.5, 113.0, 115.0, 117.5 ¿ 119.5, 122.5 ¿ 123.0, 131.0, 131.5 and 132.0 cm from the hub.There was no evidence of ballooning of the catheter.Conclusions: evaluation of the returned ace68 confirmed kinks along the distal shaft.If the device is forcefully advanced against resistance, damage such as this may occur.During functional testing, the ace68 was advanced through a demonstration neuron max without an issue.The root cause of resistance during the procedure could not be determined.Further evaluation revealed additional kinks along the device.This damage was likely incidental to the reported complaint.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.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information received: section b.Box 5.Describe event or problem.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system ace 68 reperfusion catheter (ace68) and neuron max 6f 088 long sheath (neuron max).During the procedure, the physician experienced resistance when tracking the ace68 through the neuron max to the target location.Therefore, the ace68 was removed from the patient.On the back table, the physician observed kinking at the distal tip of the ace68 and while flushing, the distal tip expanded.The procedure was completed using a new ace68 and the same neuron max.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
• MDR Report Key: 11132435
• Report Number: 3005168196-2021-00031
• Device Sequence Number: 3247206
• Product Code: NRY
• UDI-Device Identifier: 00814548016535
• UDI-Public: 00814548016535
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• PMA/510(K) Number: K161640
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/09/2020
• 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: 12/18/2020
• Device Model Number: 5MAXACE068
• Device Catalogue Number: 5MAXACE068
• Device Lot Number: F81082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 01/20/2021; 01/14/2005
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 01/27/2021; 06/18/2021
• 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