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

Catalog Number	RBY4C2060
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2018
Type of Reportable Event	Malfunction
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 had offset coil winds along its length.While attempting to re-sheath the returned ruby coil with a demonstration introducer sheath, resistance was encountered and the ruby coil could not be re-sheathed.Therefore, the ruby coil could not be functionally tested through a demonstration microcatheter.Conclusions: evaluation of the returned ruby coil revealed that the embolization coil winds were offset.If the embolization coil is forcefully advanced against resistance offset coil winds may occur.If the ruby coil is returned to penumbra without the introducer sheath protecting the embolization coil, offset coil winds may occur.During the functional test, while attempting to re-sheath the returned ruby coil with a demonstration introducer sheath, resistance was encountered and the ruby coil could not be re-sheathed.Therefore, the ruby coil could not be functionally tested through a demonstration microcatheter.The offset coil winds likely contributed to the resistance encountered during the functional test preventing the ruby coil from being functionally tested.The root cause of the reported resistance during the procedure could not be determined.The lantern identified in the complaint was not returned to penumbra for evaluation.Penumbra coils and catheters 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, while attempting to advance a ruby coil through a lantern delivery microcatheter (lantern), the physician felt like the ruby coil was ¿hitting a wall¿ after advancing it approximately half way into the lantern; therefore, it was removed.The procedure was completed using other ruby coils and the same lantern.It should be noted that the lantern was flushed multiple times.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7820018
• Report Number: 3005168196-2018-01687
• Device Sequence Number: 2447186
• Product Code: HCG
• UDI-Device Identifier: 00814548013251
• UDI-Public: 00814548013251
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• 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
• Report Date (Section B): 07/30/2018
• 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: 06/25/2025
• Device Catalogue Number: RBY4C2060
• Device Lot Number: F77905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 08/27/2018
• 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