MAUDE Adverse Event Report: PENUMBRA, INC. MAX DELIVERY DEVICE; NRY

Catalog Number	J7XBKIT132
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2022
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 left middle cerebral artery (mca) using a penumbra system red 72 reperfusion catheter (red72), a penumbra system jet 7 max reperfusion catheter (jet7 max), a neuron max 6f 088 long sheath (neuron max).And a guide wire.During the procedure, the physician completed one pass using the red72 and jet7 max.Next, while removing the jet7 max catheter to attach the tubing to the red72, the physician stretched and broke the jet7 max in two pieces at the distal end.Therefore, the red72 was removed containing both pieces of the jet7 max.After removal, it was noted that the red72 was also stretched and fractured.The procedure was completed using a new red72 and the same neuron max.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left middle cerebral artery (mca) using a penumbra system red 72 reperfusion catheter (red72), a max delivery device (max device), a neuron max 6f 088 long sheath (neuron max).And a guide wire.During the procedure, the physician completed one pass using the red72.Next, while attempting to make another pass, the physician advanced the red72 and max device to the target location.Subsequently, while removing the max device to attach the tubing to the red72 for aspiration, resistance was encountered and the physician stretched and broke the max device in two pieces at the distal end.Therefore, the red72 was removed containing both pieces of the max device.After removal, it was noted that the red72 was also stretched and fractured.The procedure was completed using a new red72 and the same neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report:3005168196-2022-00613.1.Section b.Box 5.Describe event or problem.2.Section d.Box 1.Brand name.Please note that the following section is being updated based on additional information provided by a penumbra sales representative on 2/27/2023: 1.Section h.Box 6.Device code 2.Evaluation of the returned max delivery device confirmed that the device was fractured and revealed stretching along the device shaft.If the max delivery device is retracted against resistance, damage such as stretching and subsequent fracture may occur.Based on the reported complaint, this damage occurred during retraction of the max delivery device within the red72 after a successful pass.The root cause of resistance could not be determined.Evaluation of the returned red72 confirmed that the catheter was stretched but did not reveal the reported fracture.This damage typically occurs due to retraction against resistance.The root cause of the resistance could not be determined.Resistance was experienced when retracting the max delivery device within the red72 lumen.This may have contributed to difficulty experienced when removing the devices together.Further evaluation revealed kinks along the catheter shaft.This damage was incidental to the reported complaint and likely occurred during packaging of the device for return to penumbra.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 number: 1.3005168196-2022-00614.

• Brand Name: MAX DELIVERY DEVICE
• 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: 16088134
• Report Number: 3005168196-2022-00613
• Device Sequence Number: 15113354
• Product Code: NRY
• UDI-Device Identifier: 00815948023260
• UDI-Public: 815948023260
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K191946
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2023
• 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: 07/26/2024
• Device Catalogue Number: J7XBKIT132
• Device Lot Number: C00000054
• 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: 12/08/2022
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2021
• 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: 52 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005