MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD

Catalog Number	4004C0820
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly inside its introducer sheath.The pusher assembly was fractured approximately 39.5 cm from the proximal end.The pusher assembly was kinked in multiple locations.The embolization coil was detached from its pusher assembly.Conclusions: evaluation of the returned pc400 revealed that the pusher assembly was fractured.If the device is forcefully advanced against resistance, damage such as a kink may occur.Further manipulation of a kinked device, may result in a fracture.If the pc400 pusher assembly fractures it will likely allow the pull wire to retract from the ddt, detaching the embolization coil.Evaluation of the returned px slim revealed that the catheter was fractured.If the device is forcefully advanced against resistance, damage such as a kink may occur.If the px slim was forcefully mishandled while kinked, it may worsen to a fracture.There was no damage indicated to the px slim in the reported complaint; therefore, the px slim fracture may have been incidental and occurred post-procedure.Penumbra coils and 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the posterior communicating artery (pca) using penumbra coils 400 (pc400).During the procedure, the physician advanced approximately one centimeter of a pc400 through a px slim delivery microcatheter (px slim).While retracting the pc400 back into the microcatheter for re-positioning, the pc400 unintentionally detached within px slim.Therefore, the px slim was removed with the detached pc400 inside.The procedure was completed using additional coils and a new microcatheter.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8082379
• Report Number: 3005168196-2018-02281
• Device Sequence Number: 10826033
• Product Code: HCG
• UDI-Device Identifier: 00814548010922
• UDI-Public: 00814548010922
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/22/2018
• 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: 02/19/2025
• Device Catalogue Number: 4004C0820
• Device Lot Number: F74521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• 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: 10/22/2018
• Initial Report FDA Received Date: 11/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Date Report Sent to FDA: 01/01/2005