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

Catalog Number	RBY4C2060
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2019
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 in the right gonadal vein using ruby coils, a non-penumbra microcatheter, a non-penumbra diagnostic catheter, and a non-penumbra sheath.During the procedure, sixteen coils were successfully implanted in the target location.While advancing a ruby coil into the target vessel, the diagnostic catheter and sheath migrated unbeknownst to the physician.Subsequently, the microcatheter and ruby coil migrated out of the target vessel.The physician then attempted to retract the ruby coil and navigate the microcatheter and diagnostic catheter back to the target location; however, the ruby coil unintentionally detached.In an attempt to remove the detached ruby coil, all devices were withdrawn; however, the proximal part of the ruby coil remained in the inferior vena cava (ivc).Therefore, the physician used a snare to successfully remove the ruby coil.The procedure was completed using the same catheters and additional ruby 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: 9513329
• Report Number: 3005168196-2019-02417
• Device Sequence Number: 399313
• Product Code: HCG
• UDI-Device Identifier: 00814548019123
• UDI-Public: 00814548019123
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• 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): 12/04/2019
• 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: 05/14/2026
• Device Catalogue Number: RBY4C2060
• Device Lot Number: F83478
• 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: 12/04/2019
• Initial Report FDA Received Date: 12/23/2019
• 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: 63 YR
• Date Report Sent to FDA: 01/01/2005