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

Catalog Number	RBY2C0630
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the embolization coil was intact with the pusher assembly.The embolization coil was damaged on the distal end of the introducer sheath and clotted blood was visible.Conclusions: evaluation of the returned ruby coil revealed a damage embolization coil and blood clotted inside the introducer sheath.If the sheath is not properly aligned in the hub prior to advancement, offset coil winds may result.These offset coil winds will likely contribute to the inability to advance the coil into the microcatheter.Further evaluation revealed clotted blood inside the sheath.If continuous flush is not used, blood may clot on the coil contributing to difficulty advancing the coil.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the iliac artery using ruby coils.During the procedure, the physician successfully placed multiple ruby coils using a lantern delivery microcatheter (lantern).The physician then was unable to advance a ruby coil more than a few centimeters into the lantern, and therefore the ruby coil was removed.The procedure was completed using the same lantern and a new ruby coil.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: 7395895
• Report Number: 3005168196-2018-00685
• Device Sequence Number: 1094297
• Product Code: HCG
• UDI-Device Identifier: 00814548012940
• UDI-Public: 00814548012940
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 03/07/2018

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: Physician
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: RBY2C0630
• Device Lot Number: F61049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 04/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR