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

Catalog Number	RBY2C0825
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the end of the pusher assembly.The pusher assembly was kinked at approximately 5.0 cm from the proximal end of the device.Embolization coil was detached from the pusher assembly and the proximal end of the coil was unraveled.The proximal constraint sphere was detached from the embolization coil and was not returned for evaluation.Conclusions: evaluation of the returned ruby coil revealed the embolization coil was detached due to a fractured stretch resistant wire (sr wire).This damage typically occurs if the embolization coil is forcefully retracted against resistance.If the sr wire becomes fractured, it will allow the embolization coil to detach from its pusher assembly.Further evaluation revealed the embolization coil had become unraveled.If the embolization coil is further manipulated after an sr wire fracture, the embolization coil will likely become unraveled.The root cause of the resistance could not be determined.Penumbra coils 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 using ruby coils.During the procedure, the physician felt resistance while using a ruby coil and, consequently, the ruby coil unraveled.The ruby coil was removed.There was no report of an adverse effect to the patient.No further details are available.
Additional Manufacturer Narrative
This report is associated with mfr report number: 3005168196-2018-02511.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician felt resistance while advancing the first coil of the procedure, a ruby coil, and consequently, the ruby coil began to unravel.Therefore, the lantern was removed with the ruby coil inside.The physician did not place any coils during this procedure.There was no report of an adverse effect to the patient.No further details are available.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8032634
• Report Number: 3005168196-2018-02163
• Device Sequence Number: 1435511
• Product Code: HCG
• UDI-Device Identifier: 00814548012971
• UDI-Public: 00814548012971
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 10/03/2018
• 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: 12/31/2025
• Device Catalogue Number: RBY2C0825
• Device Lot Number: F81229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 12/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Date Report Sent to FDA: 01/01/2005