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

Catalog Number	RBY2C0305
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	09/10/2019
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 numbers: 3005168196-2019-01893.3005168196-2019-01894.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the collateral branch using pod packing coils (pod pc), ruby coils and, a lantern delivery microcatheter (lantern).During the procedure, the physician placed pod pcs in the target vessel using a lantern.While attempting to advance another pod pc, it unintentionally detached.Therefore, the physician used a snare device to capture the detached pod pc.However, the pod pc broke off upon being snared and, therefore, the physician advanced a larger non-penumbra catheter over the thread of the pod pc and the remaining coil was pulled into the catheter to ensure the coil did not migrate into unwanted vessel and, successfully removed the pod pc.Next, the physician advanced a ruby coil into the lantern; however, it became stuck and would not advance any further.Therefore, the ruby coil was removed.The procedure was completed using a non-penumbra managed ventricular pacing.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: 9182837
• Report Number: 3005168196-2019-01892
• Device Sequence Number: 2811540
• Product Code: HCG
• UDI-Device Identifier: 00814548018546
• UDI-Public: 00814548018546
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 09/10/2019
• 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 Catalogue Number: RBY2C0305
• Device Lot Number: F88309
• 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: 09/10/2019
• Initial Report FDA Received Date: 10/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Patient Weight: 14
• Date Report Sent to FDA: 01/01/2005