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

Catalog Number	RBY4C0415
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Results: the ruby coil stretch resistant wire (sr wire) was fractured and the coil was unraveled.The proximal constraint was fractured from the embolization coil and was not returned for evaluation.Coagulated blood was found present throughout the embolization coil.The ruby embolization coil was detached from its pusher assembly and the pusher assembly was not returned for evaluation.Therefore, the ruby coil could not be functionally tested.Conclusions: evaluation of the returned ruby coil revealed a fractured sr wire.The proximal constraint was fractured from the embolization coil.After a coil takes shape within the vessel, it may be difficult to retract, and resistance may be experienced.If the device is forcefully retracted against resistance, damage such as a fractured sr wire may occur.Further evaluation revealed an unraveled embolization coil.If a device with a fractured sr wire is further manipulated, this may cause the embolization coil to unravel.Further evaluation revealed blood coagulated on the embolization coil.If blood coagulated on the device, this may have contributed to resistance while retracting the device.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, while attempting to advance a ruby coil into a non-penumbra microcatheter, the physician experienced resistance as the coil started to form in the vessel, subsequently; the ruby coil unintentionally detached.Therefore, the physician used a snare device to removed the entire detached ruby coil.The procedure was completed using vascular plug.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7785272
• Report Number: 3005168196-2018-01566
• Device Sequence Number: 2076691
• Product Code: HCG
• UDI-Device Identifier: 00814548013176
• UDI-Public: 00814548013176
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• 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): 07/17/2018
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/26/2025
• Device Catalogue Number: RBY4C0415
• Device Lot Number: F80732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• 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: 07/17/2018
• Initial Report FDA Received Date: 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 01/01/2005