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

Model Number	5MAXACE068
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right internal carotid artery (ica) using a penumbra system ace 68 reperfusion catheter (ace68) and a non-penumbra sheath.During the procedure, the physician experienced resistance while advancing the ace68 through the sheath.It was reported that the physician made several attempts to advance the ace68 through the sheath but the attempts were unsuccessful.Therefore, the ace68 was removed.Upon removal, the physician noticed that the ace68 was fractured approximately 20 centimeters from the distal end.The procedure was completed using a new ace68 and the same non-penumbra sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Please note that the following section was updated on this follow-up #01 mfr report 3005168196-2022-00107: 1.Section b.Box 5.Describe event or problem evaluation of the returned ace68 revealed that the catheter was stretched.This is likely the reported fracture near the distal end.If the ace68 is manipulated against resistance during use, damage such as stretching may occur.Further evaluation revealed kinks in the catheter shaft.This damage was incidental to the reported complaint and may have occurred during packaging.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.Note: based on the investigation findings, this is not considered a reportable event.This event did not and, if it were to recur, it would not cause or contribute to serious deterioration or death.H3 other text : placeholder.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right internal carotid artery (ica) using a penumbra system ace 68 reperfusion catheter (ace68) and a non-penumbra sheath.During the procedure, the physician experienced resistance while advancing the ace68 through the sheath.It was reported that the physician made several attempts to advance the ace68 through the sheath but the attempts were unsuccessful.Therefore, the ace68 was removed.Upon removal, the physician noticed that the ace68 was stretched approximately 20 centimeters from the distal end.The procedure was completed using a new ace68 and the same non-penumbra sheath.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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 13691052
• Report Number: 3005168196-2022-00107
• Device Sequence Number: 1869131
• Product Code: NRY
• UDI-Device Identifier: 00814548016535
• UDI-Public: 00814548016535
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K161640
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2022
• 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: 12/29/2023
• Device Model Number: 5MAXACE068
• Device Catalogue Number: 5MAXACE068
• Device Lot Number: H11048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/11/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2020
• 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: 59 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005