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

Catalog Number	RBY4C0406
Medical Device Problem Codes	Break (1069); Migration (4003); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 3005168196-2018-01706.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal mammary arteries using pod packing coils (podjs) and ruby coils.During the procedure, the physician accidentally kinked the pusher assembly of a podj while advancing into a lantern delivery microcatheter (lantern) and, therefore, the podj was removed.The physician then successfully placed another podj.Later in the procedure, while attempting to place the last ruby coil, a coil loop popped out into the origin of the right internal mammary artery into the right subclavian artery.The physician therefore attempted to remove the ruby coil using a snare device, however, while retracting the ruby coil within the catheter, the ruby coil broke.The physician removed the snare with a piece of the coil attached, a piece of the coil stuck within the catheter, and with another piece inside the mammary artery with the tail in the subclavian artery.The physician then made a new access point in the brachial artery and advanced a new catheter to the right subclavian artery.Another snare device was advanced through this access site to retrieve the rest of the ruby coil from the subclavian artery.All pieces of the ruby coil were able to be successfully removed.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: 7834801
• Report Number: 3005168196-2018-01705
• Device Sequence Number: 19328154
• Product Code: HCG
• UDI-Device Identifier: 00814548013169
• UDI-Public: 00814548013169
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2018
• 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: 07/04/2023
• Device Catalogue Number: RBY4C0406
• Device Lot Number: F64736
• Was Device Available for Evaluation?: No
• 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: 07/31/2018
• Initial Report FDA Received Date: 08/30/2018
• 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: Life Threatening; Required Intervention
• Patient Age: 3 YR
• Date Report Sent to FDA: 01/01/2005