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

Model Number	RBY2C2060-B
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2020
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.This report is associated with mfr report number: 3005168196-2020-00901.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using a pod packing coil (pod pc), ruby coils, and lantern delivery microcatheter (lantern).During the procedure, the physician advanced a pod10 outflow of the aneurysm; however, the coil was too large for the vessel.Therefore, the pod10 was removed and the physician successfully placed a pod8.Next, while advancing a pod pc through the lantern, the physician experienced resistance and, therefore, the pod pc was removed, and a new pod pc was placed in the vessel.Afterwards, the physician experienced resistance while advancing a ruby coil through the lantern; therefore, the physician re-sheathed the ruby coil and tried to advance the same ruby coil through the lantern; however, the same issue occurred.Therefore, the ruby coil was removed.It was reported that the lantern was flushed after each time a coil was delivered and there was no noticeable damage to the pusher assembly to the pod10, pod pc and, ruby coil were not kinked.The procedure was completed using additional pod coils, pod pcs, ruby 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 kinked approximately 9.0 cm from its proximal end.The embolization coil was detached from its pusher assembly inside its introducer sheath.The pull wire was in its initial position within the ddt alignment feature.Conclusions: evaluation of the returned pod pc revealed an undamaged, functional device.During the functional test, the pod pc was advanced through a demonstration lantern without an issue.The root cause of the reported complaint could not be determined.Evaluation of the returned ruby coil revealed a embolization coil was detached from its pusher assembly inside its introducer sheath.If the ruby coil is forcefully retracted against resistance, the pusher assembly may elongate beyond the length of the pull wire and allow the embolization coil to detach from its pusher assembly.The root cause of resistance could not be determined.Further evaluation of the returned ruby coil revealed a kink in the pusher assembly.This kink was likely incidental to the reported complaint.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: 1.3005168196-2020-00901 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: 10248656
• Report Number: 3005168196-2020-00902
• Device Sequence Number: 2426282
• Product Code: HCG
• UDI-Device Identifier: 00814548019284
• UDI-Public: 00814548019284
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• 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): 06/16/2020
• 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: RBY2C2060-B
• Device Catalogue Number: RBY2C2060
• Device Lot Number: F87467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 08/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Date Report Sent to FDA: 01/01/2005