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

Model Number	5MAXACE068KIT
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
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), non-penumbra guiding catheter, microcatheter and guidewire.During the procedure, the physician encountered resistance when advancing the ace68 with a few centimeters of the microcatheter out.The physician also encountered resistance when retrieving the microcatheter.It was reported there was a slight kink 85 millimeters from the hub of microcatheter.However, the ace68 was not found to be kinked.The procedure was completed by using a non-penumbra aspiration catheter, microcatheter and stent retriever and the same guiding catheter.There was no report of an adverse effect to the patient.
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), non-penumbra guiding catheter, microcatheter and guidewire.During the procedure, the physician encountered resistance when advancing the ace68 with a few centimeters of the microcatheter out.The physician also encountered resistance when retrieving the microcatheter.It was reported there was a slight kink 85 millimeters from the hub of microcatheter.The proximal shaft of ace68 was ovalized.The procedure was completed by using a non-penumbra aspiration catheter, microcatheter and stent retriever and the same guiding catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was updated for clarification: 1.Section b.Box 5.Describe event or problem.Evaluation of the returned ace68 revealed that the proximal shaft of the catheter was ovalized.If the ace68 is forcefully mishandled during use, damage such as an ovalization may occur.During the functional test, a demonstration lantern was advanced and retracted through the returned ace68 without an issue.The root cause of the reported resistance could not be determined.Penumbra catheters are visually 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 ACE 68 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11649836
• Report Number: 3005168196-2021-00727
• Device Sequence Number: 19747255
• Product Code: NRY
• UDI-Device Identifier: 00814548016603
• UDI-Public: 00814548016603
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K161640
• 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): 03/15/2021
• 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: 06/27/2022
• Device Model Number: 5MAXACE068KIT
• Device Catalogue Number: 5MAXACE068KIT
• Device Lot Number: F91450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Date Report Sent to FDA: 01/01/2005