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

Model Number	RBY2C0430-B
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned ruby coil revealed that the embolization coil had offset coil winds.If the device is forcefully manipulated against resistance during the procedure, damage such as offset coil winds may occur.This damage likely contributed to the coil''s inability to take its intended shape during the procedure.The root cause of the resistance during the procedure could not be determined.Further evaluation of the device revealed that the pet lock was separated and pull tube was retracted on the proximal end of the pusher assembly, and the embolization coil was detached from the pusher assembly.The detached embolization coil was likely a result of the pet lock being separated and pull tube being retracted, and the root cause of the separated pet lock could not be determined.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.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 gastroduodenal artery (gda) using ruby coils and a non-penumbra microcatheter.During the procedure, resistance was encountered while advancing the first ruby coil into the microcatheter.It was also reported that the ruby coil would not take its intended shape despite multiple attempts.Therefore, the ruby coil was removed.The procedure was completed using a pod coil and the same microcatheter.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: 12037170
• Report Number: 3005168196-2021-01377
• Device Sequence Number: 3564521
• Product Code: HCG
• UDI-Device Identifier: 00814548018607
• UDI-Public: 00814548018607
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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): 06/21/2021
• 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 Model Number: RBY2C0430-B
• Device Catalogue Number: RBY2C0430
• Device Lot Number: F104453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• 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: 05/26/2021
• Initial Report FDA Received Date: 06/21/2021
• 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
• Date Report Sent to FDA: 01/01/2005