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

Catalog Number	RBY2C0630
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2019
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a fistula off the left main coronary artery using ruby coils.During the procedure, the physician placed a pod5 and two ruby coils in the target vessel using a lantern delivery microcatheter (lantern).However, after detaching the second ruby coil as the third coil, the physician noticed a few proximal coil loops moved back.It was reported that the physician did not want the coil to land too proximal; therefore, a non-penumbra snare device was advanced through a non-penumbra diagnostic catheter to snare the ruby coil.During removal, the ruby coil broke the diagnostic catheter; therefore, the physician docked the snare device to the coil filament as a wire extender.Next, the physician re-advanced the same lantern through the diagnostic catheter and over the broken ruby coil and carefully pulled the filament back while advancing the lantern forward.The remainder of the ruby coil was recaptured into the lantern and the entire system was successfully removed.The procedure was ended at this point and the final angiogram showed occlusion of the fistula as well as a normal and unobstructed flow in the coronary arteries.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: 8946929
• Report Number: 3005168196-2019-01658
• Device Sequence Number: 2150980
• Product Code: HCG
• UDI-Device Identifier: 00814548012940
• UDI-Public: 00814548012940
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/31/2019
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/02/2025
• Device Catalogue Number: RBY2C0630
• Device Lot Number: F78492
• 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: 07/31/2019
• Initial Report FDA Received Date: 08/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 9 YR
• Date Report Sent to FDA: 01/01/2005