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

Catalog Number	RBY2C1660
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2019
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.This report is associated with mfr report number: 3005168196-2019-00382.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using ruby coils.During the procedure, the physician successfully placed two ruby coils using a non-penumbra microcatheter.The physician then felt resistance and was unable to advance or retract another ruby coil within the microcatheter.Consequently, the ruby coil unintentionally detached within the microcatheter.The physician was able to pull the ruby coil out of the microcatheter, and then another ruby coil was successfully placed.The physician then again felt resistance and was unable to advance or retract another ruby coil.This ruby coil unintentionally detached within the microcatheter as well, and was removed by pulling the coil out from the proximal end of the microcatheter.The procedure was then completed using a new ruby coil and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed on the initial mfr report and is being updated on this follow-up # 01 mfr report: 1.Patient code.Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 83.0 cm from the proximal end.The stretch resistant wire (sr wire) was fractured and the embolization coil was detached from its pusher assembly.The proximal constraint sphere was inside the distal detachment tip (ddt).Conclusions: evaluation of the first returned ruby coil revealed that the pet lock was intact and the embolization coil was detached from its pusher assembly.If the device is forcefully retracted against resistance and the pusher assembly elongates beyond the reach of the pull wire, the pull wire may retract out of the ddt allowing the embolization coil to detach.The root cause of resistance could not be determine.Further evaluation revealed bends along the length of the pusher assembly¿s distal polymer section.These bends may have occurred due to elongation of the pusher assembly.Evaluation of the second returned ruby coil revealed that the sr wire was fractured.If the device is forcefully retracted against resistance, damage such as this may occur.The root cause of the initial resistance could not be determined.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: 1.3005168196-2019-00381.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8381044
• Report Number: 3005168196-2019-00381
• Device Sequence Number: 19285442
• Product Code: HCG
• UDI-Device Identifier: 00814548013053
• UDI-Public: 00814548013053
• Combination Product (Y/N): Y
• Initial Reporter Country: SN
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2019
• 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: 05/30/2026
• Device Catalogue Number: RBY2C1660
• Device Lot Number: F83761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Date Report Sent to FDA: 01/01/2005