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

Model Number	5MAXACE068KIT-R
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2021
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.This report is associated with mfr report numbers: 3005168196-2021-01482, and 3005168196-2021-01484.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a neuron max 6f 088 long sheath (neuron max) and a penumbra system ace 68 reperfusion catheter (ace68).During the procedure, the physician experienced resistance while attempting to advance the ace68 through the distal end of the neuron max.Therefore, the ace68 was removed.Afterwards, the physician attempted to advance a new ace68 through the neuron max; however the same issue occurred.Therefore, the ace68 and neuron max were removed.The procedure was completed using a new ace68 and new neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned neuron max revealed an undamaged, functional device.Evaluation of the first returned ace68 revealed an ovalization on the proximal shaft.If the device is forcefully pinched or gripped during use, damage such as this may occur.During functional testing, the ace68 was able to be advanced through the returned neuron max without an issue until the ovalization in the ace68 met the rhv, then resistance was experienced and the ace68 could not be advanced any further.Evaluation of the second returned ace68 revealed that the device was ovalized throughout its length and the distal tip was slightly ovalized.If the device is mishandled at extreme angles during insertion or retraction from a parent catheter, damage such as ovalizations may occur.During functional testing, resistance was experienced while attempting to advance the ace68 through the returned neuron max due to the ovalizations, and the ace68 could not be advanced any further.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.This report is associated with mfr report numbers: 1.3005168196-2021-01482; 2.3005168196-2021-01484.

• 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: 12132130
• Report Number: 3005168196-2021-01483
• Device Sequence Number: 19731115
• Product Code: NRY
• UDI-Device Identifier: 00815948022850
• UDI-Public: 00815948022850
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 11/10/2021
• 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: 01/13/2024
• Device Model Number: 5MAXACE068KIT-R
• Device Catalogue Number: 5MAXACE068KIT
• Device Lot Number: H11082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• 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: 06/11/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2021
• 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: 61 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005