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

Catalog Number	RBY2C1035
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.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 in the internal iliac artery (iia) using a lantern delivery catheter (lantern), ruby coils and a ruby coil detachment handle (handle).During the procedure, the hospital staff inadvertently knocked the lantern and the handle to the floor while they were on the sterile field.The lantern and handle dropped on the floor prior to use and therefore, were not used in the procedure.A second lantern and handle were then opened.Once gaining access to the iia, the physician advanced the second lantern over a guide-wire and attempted to advance a ruby coil through the lantern; however, the physician experienced resistance while advancing the ruby coil and, consequently, 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 physician inspected, then re-inserted the same lantern into the patient's body and placed a new ruby coil with no issues.After this, another ruby coil was inadvertently kinked upon removal from the packaging.The damage to this ruby coil was found prior to use and therefore, the ruby coil was not used in the procedure.The procedure was completed using another ruby coil, the same handle and the same lantern.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 67.5 cm from the proximal end.Bends and kinks were present along the pusher assembly approximately 29.5, 48.0 and from 141.5 ¿ 160 cm from the proximal end.The pull wire was completely retracted out of the distal fractured segment of the pusher assembly.Conclusions: evaluation of the returned ruby coil pusher assembly revealed a fracture.If the device is forcefully mishandled while advancing 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 is fractured, the pull wire will likely retract out of the pusher assembly distal detachment tip (ddt) releasing the embolization coil.The lantern identified in the complaint was not returned for evaluation; therefore, the root cause of the initial resistance experienced during the procedure could not be determined.Further evaluation of the returned ruby coil pusher assembly revealed additional bends and kinks.These damages were likely incidental to the reported complaint.The second ruby coil was not returned for evaluation.Penumbra coils 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.H3 other text : placeholder.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8802850
• Report Number: 3005168196-2019-01405
• Device Sequence Number: 326869
• Product Code: HCG
• UDI-Device Identifier: 00814548013008
• UDI-Public: 00814548013008
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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): 06/18/2019
• 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: 04/15/2026
• Device Catalogue Number: RBY2C1035
• Device Lot Number: F82877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Date Report Sent to FDA: 01/01/2005