MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER; NRY

Catalog Number	RED72KIT
Medical Device Problem Codes	Leak/Splash (1354); Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system red 72 reperfusion catheter (red72), a non-penumbra stent retriever, a non-penumbra microcatheter, and a guidewire.During the procedure, the physician advanced a red72 into the target location.Next, the physician advanced a microcatheter through the red72 and subsequently, delivered the stent retriever using the microcatheter.The physician then completed the first pass using the red72 and the stent retriever.The physician then experienced resistance while removing the red72 and the stent retriever for the next pass.While flushing the red72 the physician noticed that the red72 was unwound and was found to be leaking one third away from the distal tip.Therefore, the red72 was not used.The thrombectomy was successful and the procedure ended at this point.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
Evaluation of the returned red72 revealed that the device was stretched and ovalized on the distal shaft.This is likely the reported catheter unwound near the distal tip.This damage typically occurs if the device is retracted against resistance during use.The root cause of the resistance could not be determined.During evaluation, the red72 was flushed with air while submerged in the water and no leak was observed.Therefore, the reported leak near the distal tip of the catheter could not be confirmed.Further evaluation revealed kinks and ovalizations on the catheter shaft.This damage was likely incidental to the 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 was incorrectly reported on the follow-up #01 and is being corrected on this follow-up #02 mfr report:3005168196-2023-00052.1.Section h.Box 10./11.Narrative/corrected data.Evaluation of the returned red72 revealed that the device was stretched and ovalized on the distal shaft.This is likely the reported catheter unwound near the distal tip.This damage typically occurs if the device is retracted against resistance during use.The root cause of the resistance could not be determined.During evaluation, the red72 was flushed with air while submerged in the water and no leak was observed.Therefore, the reported leak near the distal tip of the catheter could not be confirmed.Further evaluation revealed kinks and ovalizations on the catheter shaft.This damage was likely incidental to the 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.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.

• Brand Name: PENUMBRA SYSTEM RED 72 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: 16269025
• Report Number: 3005168196-2023-00052
• Device Sequence Number: 6405550
• Product Code: NRY
• UDI-Device Identifier: 00815948023932
• UDI-Public: 815948023932
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K211654
• 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,Followup
• Report Date (Section B): 12/14/2023
• 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: 11/17/2024
• Device Catalogue Number: RED72KIT
• Device Lot Number: F110890
• 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: 01/03/2023
• Supplement Date Received by Manufacturer: 02/03/2023; 01/14/2005
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 03/02/2023; 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2021
• 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: 72 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005