MAUDE Adverse Event Report: PENUMBRA, INC. MIDWAY 62 DELIVERY CATHETER; DQY, QJP

Catalog Number	62MWAY115
Medical Device Problem Codes	Leak/Splash (1354); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a medical procedure in the internal carotid artery (ica) using a midway 62 delivery catheter.During the procedure, the physician advanced the midway 62 delivery catheter to the target location to perform a contrast run.While attempting to inject contrast through the midway 62 delivery catheter, the physician noticed that the midway 62 delivery catheter was leaking contrast from a kink on the strain relief.Therefore, the midway 62 delivery catheter was removed.The procedure was completed using a non-penumbra access catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned midway 62 confirmed it was leaking from a kink underneath the strain relief.Kinks near the hub typically occur if the device is retracted from its packaging at an angle, or, if the device is manipulated at angles during flushing.A kink may result in a small hole in the catheter resulting in fluid leaking from the lumen.The root cause of the kink could not be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.

• Brand Name: MIDWAY 62 DELIVERY CATHETER
• Common Device Name: DQY, QJP
• 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: 19608734
• Report Number: 3005168196-2024-00232
• Device Sequence Number: 8204440
• Product Code: DQY
• UDI-Device Identifier: 00815948028197
• UDI-Public: 00815948028197
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K233201
• 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
• Report Date (Section B): 06/25/2024
• 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 Catalogue Number: 62MWAY115
• Device Lot Number: F00009004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2024
• 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: 05/28/2024
• Initial Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2023
• 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: Unknown
• Date Report Sent to FDA: 01/01/2005