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

Model Number	RBY2C0320-A
Medical Device Problem Codes	Retraction Problem (1536); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2020
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 a ruby coil and a lantern delivery microcatheter (lantern).During the procedure, the physician advanced a ruby coil into the target location; it was reported that the ruby coil was too long; therefore, the physician decided to remove it.While retracting the ruby coil back into its introducer sheath, the ruby coil got stuck at the tip of its introducer sheath.Subsequently, the physician was unable to retract the ruby coil back into its the introducer sheath.Therefore, the physician pulled the introducer sheath of the lantern shaft so that a small part of the ruby coil looked out the introducer sheath sleeve.The procedure was completed using a new ruby coil and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: 3005168196-2020-00837.Section g.Box 3.Report source.Results: the pet lock was intact on the proximal end of the pusher assembly.The embolization coil was intact with the pusher assembly.Offset coil winds were present along the length of the embolization coil, and the distal end of the embolization coil was knotted and sticking out of the distal tip of the introducer sheath.Conclusions: evaluation of the returned ruby coil revealed offset coil winds along the embolization coil and the distal tip of the embolization coil was in a knot.If the device is manipulated against resistance, damage such as this may occur.During functional testing, the ruby coil was advanced out of its introducer sheath with resistance due to the offset coil winds.Subsequently, while re-sheathing the ruby coil, resistance was experienced due to the offset coil winds and the ruby coil could not be re-sheathed.These offset coil winds likely contributed to the reported complaint.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: 10201683
• Report Number: 3005168196-2020-00837
• Device Sequence Number: 14011761
• Product Code: HCG
• UDI-Device Identifier: 00814548012834
• UDI-Public: 00814548012834
• Combination Product (Y/N): Y
• Initial Reporter Country: AU
• PMA/510(K) Number: K173614
• 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): 06/05/2020
• 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: 12/06/2023
• Device Model Number: RBY2C0320-A
• Device Catalogue Number: RBY2C0320
• Device Lot Number: C11131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/05/2020
• Supplement Date Received by Manufacturer: 07/31/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 08/30/2020
• 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