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

Catalog Number	RBY2C2060
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2019
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.This report is associated with mfr report number: 3005168196-2019-00739.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using ruby coils.During the procedure, after advancing the ruby coil into the lantern delivery microcatheter (lantern), approximately 8 centimeters from the distal tip, it was met with a hard stop and the ruby coil was unable to advance any further.Therefore, the ruby coil was retracted back into the introducer sheath.While attempting to advance the same ruby coil, the physician experienced resistance and was unable to advance the ruby coil out of the introducer sheath and, therefore, it was removed.Next, while advancing a new ruby coil into the microcatheter, the physician experienced resistance and decided to retract the coil back into the introducer sheath.While retracting the ruby coil, it unintentionally detached with half of the coil inside the introducer sheath and half of the coil out of the introducer sheath.The physician was able to successfully remove the detached ruby coil by removing the introducer sheath from the microcatheter.The procedure was completed using new ruby coils with the same microcatheter.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 embolization coil was detached from its pusher assembly and had offset coil winds.The pusher assembly was undamaged.Conclusions: conclusions: evaluation of the first returned ruby coil revealed that the pusher assembly was kinked and the embolization coil had offset coil winds.If the device is forcefully advanced against resistance, damage such as this may occur.The kink and offset coil winds likely contributed to the reported inability to advance the device out of its introducer sheath during the second attempt.During the functional testing, resistance was encountered as the embolization coil was attempted to be retracted through its introducer sheath and the ruby coil could not be retracted any further.The root cause of the initial resistance was unable to be determined.Evaluation of the second returned ruby coil confirmed that the embolization coil was detached from its pusher assembly and the pet lock was intact on the proximal end of the pusher assembly.If the device is forcefully retracted against resistance, the pusher assembly may elongate beyond the reach of the pull wire and result in the embolization coil detaching from its pusher assembly.The returned ruby coil also had offset coil winds.This damage may have occurred due to forceful retraction against resistance during the procedure.Further evaluation of the returned ruby coil revealed that the pusher assembly was undamaged, and the pet lock was intact on the proximal end of the pusher assembly.This indicates that no attempts were made to detach the embolization coil from its 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.This report is associated with mfr report number: (b)(4) 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: 8523079
• Report Number: 3005168196-2019-00740
• Device Sequence Number: 1871058
• Product Code: HCG
• UDI-Device Identifier: 00814548013077
• UDI-Public: 00814548013077
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• 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): 03/19/2019
• 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: 07/25/2026
• Device Catalogue Number: RBY2C2060
• Device Lot Number: F84946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 07/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Date Report Sent to FDA: 01/01/2005