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

Catalog Number	RBY2C4060
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a pulmonary arteriovenous malformation (avm) using ruby coils.During the procedure, the physician successfully placed seventeen ruby coils in the avm using a lantern delivery microcatheter (lantern).While advancing the eighteenth ruby coil through the lantern, the physician experienced resistance.The physician continued to advance the ruby coil against resistance, and consequently, the pusher assembly of the ruby coil broke and the ruby coil unintentionally detached within the lantern.Therefore, the lantern containing the detached ruby coil was removed and the ruby coil was flushed out.The procedure was completed using the same lantern and additional ruby coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was fractured approximately 33.5 cm from the proximal end.Conclusions: evaluation of the returned ruby coil confirmed a fractured pusher assembly and detached embolization coil.If the device is forcefully advanced against resistance, damage such as a kink may occur.If a kinked device is further manipulated, the kink may worsen to a fracture.If the pusher assembly fractures, the pull wire will likely retract out of the pusher assembly distal detachment tip (ddt).If this occurs, the proximal constraint sphere will release from the ddt and allow the embolization coil to detach.The lantern was used to complete the procedure; therefore, the root cause of the resistance could not be determined.The embolization coil was not returned for evaluation.Evaluation of the returned lantern revealed an ovalization on the distal tip.The lantern was used to complete the procedure; therefore, the ovalization was likely incidental to the reported complaint and may have occurred post procedure.Penumbra coils and catheters are 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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9169864
• Report Number: 3005168196-2019-01902
• Device Sequence Number: 2591852
• Product Code: HCG
• UDI-Device Identifier: 00814548019437
• UDI-Public: 00814548019437
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2019
• 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: 10/03/2026
• Device Catalogue Number: RBY2C4060
• Device Lot Number: F86270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 11/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005