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

Catalog Number	RBY2C2860
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578); Device Handling Problem (3265)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2018
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: 3005168196-2018-00233; 3005168196-2018-00234; 3005168196-2018-00235; 3005168196-2018-00236.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a pulmonary arteriovenous malformation (pavm) using ruby coils.It was noted that the patient's anatomy was tortuous.During the procedure, while attempting to implant a ruby coil into the pavm using a lantern delivery microcatheter (lantern), the physician experienced resistance after advancing the ruby coil approximately 75% into the pavm and the coil would not advance further; therefore, it was removed.While attempting to advance a new ruby coil through the lantern, the physician experienced resistance; therefore, the lantern and coil were removed and the physician flushed clot out of the lantern.It was reported that the ruby coil was then accidentally dropped on the floor after removal from the lantern.The physician wanted to start fresh and decided to use a second lantern.After multiple attempts, the physician was able to get the lantern back engaged into the pavm and attempted to advance a new ruby coil through the lantern; however, resistance was encountered and the ruby coil would not advance.The physician then decided to end the procedure at this point and the patient will be scheduled for another procedure.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: 7240799
• Report Number: 3005168196-2018-00232
• Device Sequence Number: 10953613
• Product Code: HCG
• UDI-Device Identifier: 00814548013091
• UDI-Public: 00814548013091
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• 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): 01/08/2018

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: Physician
• Device Expiration Date: 06/14/2025
• Device Catalogue Number: RBY2C2860
• Device Lot Number: F77731
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2018
• Initial Report FDA Received Date: 02/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR