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

Model Number	RBY2C1460-B
Medical Device Problem Codes	Unraveled Material (1664); Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils, a non-penumbra microcatheter, and a non-penumbra guide catheter.During the procedure, the physician encountered resistance while advancing a ruby coil through its introducer sheath.The ruby coil was then removed and tested on the back table.However, it was noted that the ruby coil could be advanced and withdrawn.Therefore, the physician attempted to re-advance it into the microcatheter.During re-advancement, the ruby coil became stuck inside the microcatheter.While attempting to remove the ruby coil from the microcatheter, the physician encountered strong resistance.Subsequently, the ruby coil became unraveled.Therefore, the ruby coil was completely removed from the procedure.The procedure was completed using an additional ruby coil, other penumbra coils, and a non-penumbra coil.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections have been updated based on additional information provided on 01/08/2020: 1.Section b.Box 5.Describe event or problem.2.Section d.Box 10.Device available for evaluation? (do not send to fda).3.Section d.Box 10: returned to manufacturer on (mm/dd/yyyy).4.Section h.Box 3: device returned to manufacturer)? 5.Section h.Box 6.Results code 1.6.Section h.Box 6.Conclusions code 1.H3 other text : placeholder.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils, a non-penumbra microcatheter, and a non-penumbra guide catheter.During the procedure, the physician encountered resistance while advancing a ruby coil through its introducer sheath.The ruby coil was then removed and tested on the back table.However, it was noted that the ruby coil could be advanced and withdrawn.Therefore, the physician attempted to re-advance it into the microcatheter.During re-advancement, the ruby coil became stuck inside the microcatheter mid-shaft.While attempting to remove the ruby coil from the microcatheter , the physician encountered strong resistance.Subsequently, the ruby coil detached and unraveled.The procedure was completed using additional ruby coils, other penumbra coils, and a non-penumbra coil.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 at approximately 10.0 cm, 67.0 cm, 72.0 cm and 76.0 cm from the proximal end.The pusher assembly was fractured at approximately 71.0 cm from the proximal end.The pull wire was retracted from the distal detachment tip (ddt).The embolization coil was detached and not returned for evaluation.The introducer sheath was damaged at approximately 1.0 cm and 4.0 cm from its proximal end.Conclusions: evaluation of the returned ruby coil pusher assembly revealed kinks and a fracture.If the device is forcefully manipulated against resistance, damages such as these may occur.If the pusher assembly fractures, the pull wire may retract from the ddt and the embolization coil will become detached.The detached embolization coil and non-penumbra microcatheter used in the procedure were not returned for evaluation; therefore, the root cause of resistance experienced during the procedure was unable to be determined.Further investigation revealed that the introducer sheath was damaged near its proximal end.This damage was likely incidental to the complaint and may have occurred during advancement of the sheath over the kinks in the pusher assembly.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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9440480
• Report Number: 3005168196-2019-02255
• Device Sequence Number: 18896869
• Product Code: HCG
• UDI-Device Identifier: 00814548019116
• UDI-Public: 00814548019116
• 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,Followup
• Report Date (Section B): 11/12/2019
• 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 Model Number: RBY2C1460-B
• Device Catalogue Number: RBY2C1460
• Device Lot Number: F87015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 01/08/2020; 02/13/2020
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 02/03/2020; 02/28/2020
• 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