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

Catalog Number	RBY4C0305
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/25/2018
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, the physician successfully placed multiple coils using a lantern delivery microcatheter (lantern).The physician then felt resistance and was unable to advance a ruby coil through the lantern and, therefore the ruby coil was removed.It was reported that the physician thought there might be an issue with the detachment zone between the embolization coil and the pusher assembly of the ruby coil and, therefore, it was not reused.The procedure was completed using new 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 embolization coil was intact with its pusher assembly and coil was damaged at the proximal end.Coagulated blood was present on the device and inside the introducer sheath.Conclusions: evaluation of the returned ruby coil revealed a damaged embolization coil.If the introducer sheath is not properly aligned with the hub of the parent device, resistance may be experienced.If the device is forcefully advanced against resistance, the embolization coil will likely become damaged.In addition, if the embolization coil became damage due to mishandling during preparation, this damage would likely contribute to resistance when attempting to advance the device during the procedure.During functional testing, the ruby coil was able to advance through its introducer sheath and a demonstration lantern with some resistance.The lantern used in the procedure was not returned for evaluation.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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7908324
• Report Number: 3005168196-2018-01905
• Device Sequence Number: 1473167
• Product Code: HCG
• UDI-Device Identifier: 00814548018317
• UDI-Public: 00814548018317
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 08/27/2018
• 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: 05/19/2026
• Device Catalogue Number: RBY4C0305
• Device Lot Number: F83568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/27/2018
• Supplement Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Date Report Sent to FDA: 01/01/2005