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

Model Number	RBY2C4060-B
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	10/25/2019
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).During the procedure, the physician placed penumbra coils in the target vessel using the lantern.While advancing the next ruby coil, the physician encountered resistance at 30cm from the tip of the lantern; therefore, the physician decided to remove the ruby coil and flushed it with saline.While re-advancing the ruby coil, it would not advance in the lantern; therefore, it was removed.The procedure was completed using other penumbra coils and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the returned pusher assembly had bends at 55.0cm and 72.5cm.The pusher assembly was kinked and fractured at 76.0 cm, just proximal to the introducer sheath.The pull wire was retracted from the distal detachment tip (ddt) and embolization coil was detached from the pusher assembly and undamaged.The pet lock was still intact.Conclusions: the lantern used in the procedure was not returned for evaluation; therefore, cause of the initial reported resistance was unable to be determined.It was reported that the ruby coil was unable to be re-advanced into the lantern after being removed.Cause was determined to be the kinked pusher assembly.If the pusher assembly is kinked, it may be unable to advance through the introducer sheath and into the microcatheter.Subsequent fracture of the pusher assembly and detachment of the embolization coil was incidental to the reported complaint and likely occurred after the event.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.Section h.Box 6.Conclusions code 1: (b)(4).

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9438889
• Report Number: 3005168196-2019-02267
• Device Sequence Number: 19866240
• Product Code: HCG
• UDI-Device Identifier: 00814548019437
• UDI-Public: 00814548019437
• 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): 11/12/2019
• 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 Model Number: RBY2C4060-B
• Device Catalogue Number: RBY2C4060
• Device Lot Number: F91024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 12/09/2019
• Supplement Report FDA Received Date: 02/06/2020
• 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