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

Model Number	RBY2C1460-A
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/30/2020
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 splenic artery using ruby coils, a lantern delivery microcatheter (lantern), a non-penumbra sheath, a non-penumbra select catheter and a guidewire.During the procedure, the physician implanted two ruby coils in the aneurysm using the lantern.While advancing the third ruby coil through the lantern, the ruby coil unintentionally detached within the lantern in the external iliac artery.Therefore, the physician used the guidewire to push the detached ruby coil out of the lantern and into the aneurysm.It was reported that the black alignment zone (pet lock) on the ruby coil pusher assembly was not damaged.The procedure was completed using six additional coils 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 26.5 cm from the proximal end.The pusher assembly was kinked approximately 82.0 cm from the proximal end.The pull wire was retracted out of the pusher assembly distal detachment tip (ddt).The embolization coil was implanted during the procedure; therefore, it was not returned for evaluation.Conclusions: evaluation of the returned ruby coil pusher assembly confirmed a fracture.If the device is manipulated against resistance or is otherwise mishandled at extreme angles during use, damage such as a kink and subsequent fracture may occur.If the pusher assembly fractures, the pull wire will retract out of the pusher assembly ddt and detach the embolization coil.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: 10329817
• Report Number: 3005168196-2020-01029
• Device Sequence Number: 13686886
• Product Code: HCG
• UDI-Device Identifier: 00814548013046
• UDI-Public: 00814548013046
• Combination Product (Y/N): Y
• Initial Reporter Country: SZ
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2020
• 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 Model Number: RBY2C1460-A
• Device Catalogue Number: RBY2C1460
• Device Lot Number: C20355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 07/27/2020
• Supplement Report FDA Received Date: 08/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Date Report Sent to FDA: 01/01/2005