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

Model Number	RBY2C1460-B
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2020
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 in the internal iliac artery (iia) using ruby coils, and a lantern delivery microcatheter (lantern).It should be noted that the patient's anatomy was slightly tortuous and calcified.During the procedure, the physician implanted a ruby coil into the target location using the lantern.Upon advancement of the next ruby coil approximately fifteen centimeters into the lantern, the physician encountered strong resistance.The physician attempted to flush the devices; however, the issue was not resolved.Therefore, the ruby coil was no longer used in the procedure.The procedure was completed using another ruby coil, nine additional 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 pusher assembly was kinked approximately 125.5 and 127.5 cm from the proximal end of the pusher assembly.The pusher assembly mid-joint was proximal to the introducer sheath friction lock.The introducer sheath was ovalized from approximately 4.0 ¿ 5.0 cm from the proximal end.The embolization coil was undamaged and intact with the pusher assembly.Conclusions: evaluation of the returned ruby coil revealed an ovalization on the proximal end of the introducer sheath and pusher assembly kinks proximal to the introducer sheath.If the introducer sheath is ovalized, resistance may be experienced while advancing the ruby coil within its introducer sheath, and damage such as pusher assembly kinks may occur.During functional testing, resistance was experienced while attempting to advance the pusher assembly mid-joint through the ovalization in the introducer sheath and the ruby coil could not advance any further.The root cause of the introducer sheath ovalization could not be determined.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: 9862844
• Report Number: 3005168196-2020-00423
• Device Sequence Number: 2874816
• Product Code: HCG
• UDI-Device Identifier: 00814548019116
• UDI-Public: 00814548019116
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2020
• 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: 09/11/2026
• Device Model Number: RBY2C1460-B
• Device Catalogue Number: RBY2C1460
• Device Lot Number: F85818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 05/01/2020
• 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