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

Catalog Number	RBY2C0825
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	09/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 3005168196-2019-01994.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the hypogastric artery using a pod10 and ruby coils.It was noted that the patient's anatomy was extremely tortuous.During the procedure, the pod10 pusher wire became kinked during advancement through the introducer sheath.Therefore, the pod10 was removed.Next, the physician was advancing a ruby coil through lantern delivery microcatheter (lantern) towards the target location and encountered resistance while advancing around one bend in the vasculature.However, the physician decided to continue advancing the ruby coil and reported that it unintentionally detached within the lantern.The ruby coil and lantern were removed together from the patient and the physician then removed the ruby coil from the lantern.The same lantern was then re-advanced and used to complete the procedure with another 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: 9252216
• Report Number: 3005168196-2019-01995
• Device Sequence Number: 11305619
• Product Code: HCG
• UDI-Device Identifier: 00814548018850
• UDI-Public: 00814548018850
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• 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): 09/30/2019
• 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 Expiration Date: 10/02/2026
• Device Catalogue Number: RBY2C0825
• Device Lot Number: F86256
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 118
• Date Report Sent to FDA: 01/01/2005