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

Catalog Number	RBY4C0204
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was fractured approximately 5.0 cm from the proximal end and the pull wire was completely retracted out of the pusher assembly.The pusher assembly was kinked approximately 9.0 and 13.0 cm from the proximal end.The embolization coil was detached from its pusher assembly.The first ruby coil pusher assembly was fractured and the embolization coil was detached and, therefore, the ruby coil could not be functionally tested.Conclusions: evaluation of the first evaluated ruby coil revealed that the pusher assembly was fractured and the embolization coil was detached from its pusher assembly.If the device forcefully advance against resistance, damage such as a kink may occur.Subsequently, if the kinked device is further manipulated, it may result in a fracture.Further evaluation of the returned ruby coil revealed that the pull wire was completely retracted out of its pusher assembly and the embolization coil was detached.The pull wire being retracted out of the pusher assembly will likely cause the embolization coil to detach from its pusher assembly.Evaluation of the second evaluated ruby coil revealed that the sr wire was fractured and the embolization coil was detached from its pusher assembly.If the device is forcefully retracted against resistance, damage such as a fractured sr wire may occur, and result in the embolization coil detaching from its pusher assembly.The root cause of the initial resistance could not be determined.Further evaluation of the returned ruby coil revealed that the pusher assembly was kinked.These kinks likely occurred due to forceful manipulation during the procedure.The non-penumbra microcatheter identified in the complaint and the first ruby coil embolization coil were not returned to penumbra for evaluation.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.This report is associated with mfr report number: 3005168196-2018-01586.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left hepatic artery using ruby coils.During the procedure, while attempting to advance a ruby coil through a non-penumbra microcatheter, the physician experienced resistance; consequently, the ruby coil became kinked, therefore it was removed.The physician then attempted to advance another ruby coil, again resistance was felt; subsequently the coil unintentionally detached within the microcatheter; therefore, the microcatheter was removed with the detached coil inside and the coil was flushed out of the microcatheter.The procedure was completed using additional ruby coils and the same microcatheter.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: 7781823
• Report Number: 3005168196-2018-01585
• Device Sequence Number: 13843043
• Product Code: HCG
• UDI-Device Identifier: 00814548013138
• UDI-Public: 00814548013138
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/23/2026
• Device Catalogue Number: RBY4C0204
• Device Lot Number: F83017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• 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: 08/14/2018
• 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
• Patient Weight: 64
• Date Report Sent to FDA: 01/01/2005