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

Model Number	RBY4C1035-B
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.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 left internal iliac artery (iia) using ruby coils and a lantern delivery microcatheter (lantern).It was noted that the patient anatomy was tortuous, narrowed and calcified.During the procedure, while advancing the ruby coil in the middle of the lantern, the physician experienced resistance and subsequently, the physician decided to remove the ruby coil.While retracting the ruby coil, it unintentionally detached inside the lantern.Therefore, the lantern containing the ruby coil was removed.The procedure was completed using a pod coil, three pod packing coils and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was broken on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 5.0, 14.0, and 27.0 cm from its proximal end.The embolization coil was detached from the pusher assembly.Conclusions: evaluation of the returned ruby coil confirmed that the embolization was detached from the pusher assembly.Further evaluation of the ruby coil revealed that the pet lock was broken on the proximal end of the pusher assembly, and the pull wire was retracted out of the ddt.If this occur, the embolization coil will detach from its pusher assembly.Further evaluation of the returned ruby coil revealed kinks in the pusher assembly.This damage was likely incidental to the reported complaint.Penumbra coils 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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10439871
• Report Number: 3005168196-2020-01250
• Device Sequence Number: 17137549
• Product Code: HCG
• UDI-Device Identifier: 00814548018669
• UDI-Public: 00814548018669
• 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): 07/27/2020
• 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 Model Number: RBY4C1035-B
• Device Catalogue Number: RBY4C1035
• Device Lot Number: F87018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 09/23/2020
• 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