MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER; NRY

Catalog Number	RED62SKIT
Medical Device Problem Codes	Break (1069); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system red 62 reperfusion catheter (red62), a benchmark bmx 81 access system (bmx81) and non -penumbra stent retrievers.It was noted that the patient¿s anatomy was moderately tortuous.During the procedure, the physician completed four passes using the red62 with the stent retrievers.Subsequently, while retracting the red62 into the bmx81, the physician experienced resistance.The physician then attempted to manipulate the red62 to relieve the tension but was unsuccessful.Therefore, the red62 and the bmx81 were removed together.Upon removal, the red62 was noticed to be stretched, unwound, and frayed from the mid-shaft to the distal end.It was also reported that the physician decided to use a new bmx81 as a precaution, there was no noticeable damage to the bmx81.The procedure was completed using a new red62 and a new bmx81.There was no report of an adverse effect to the patient.
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.H3 other text : placeholder.
Additional Manufacturer Narrative
Evaluation of the returned red62 confirmed that the catheter was fractured.Evaluation also revealed stretching and unraveled coil winds at the fractured location.If the red62 is retracted and manipulated further against resistance, damage such as stretching and subsequent fracture may occur.The separation of the two fractured segments contributed to the unraveled coil winds.Based on the reported complaint, the root cause of resistance could not be determined.Further evaluation revealed ovalization in multiple locations along the proximal shaft and the distal fractured segment, and additional stretching on the distal fractured segment to the distal tip.This damage was incidental to the reported complaint and the root cause could not be determined.However, the stretching along the distal segment to the distal tip indicates that the red62 may have become pinned during the procedure and likely contributed to the reported resistance.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.

• Brand Name: PENUMBRA SYSTEM RED 62 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: 17333728
• Report Number: 3005168196-2023-00336
• Device Sequence Number: 7331315
• Product Code: NRY
• UDI-Device Identifier: 00815948023536
• UDI-Public: 815948023536
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K203440
• 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): 07/25/2023
• 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: 10/02/2025
• Device Catalogue Number: RED62SKIT
• Device Lot Number: F00003380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2023
• 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: 06/21/2023
• Supplement Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2022
• 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 Sex: Female
• Date Report Sent to FDA: 01/01/2005