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

Catalog Number	RBY2C1440-A
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock on the proximal end of the second ruby coil pusher assembly was intact.The pusher assembly was kinked in multiple locations along the hypotube.The coil was intact with the pusher assembly.Conclusions: evaluation of the returned devices revealed that the pusher assembly of the first ruby coil was fractured, and the distal segment of the pusher assembly was stuck inside the px slim.If the ruby coil is manipulated forcefully at extreme angles, the pusher assembly may become fractured.A fractured pusher assembly will likely cause the pull wire of the ruby coil to retract, causing the embolization coil to detach.Evaluation of the returned px slim revealed that it was kinked underneath the strain relief.This damage may have occurred due to forceful handling while advancing the first ruby coil.Further evaluation revealed a foreign substance near the distal tip of the px slim.The substance was confirmed to not be part of any penumbra product, and the root cause of this substance could not be determined.Evaluation of the second ruby coil revealed that its pusher assembly was kinked.If the ruby coil is manipulated forcefully against resistance at extreme angles, this type of damage may occur.The resistance was likely caused due to advancing the second ruby coil through the px slim that was occluded by the distal segment of the first ruby coil¿s pusher assembly.Penumbra coils are 100% functionally tested during in-process inspection.All penumbra coils and catheters are visually evaluated during in-process inspection.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: 3005168196-2016-00692, 3005168196-2016-00694.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat an arteriovenous malformation (avm) using ruby coils and a px slim delivery microcatheter (px slim).During the procedure, while the physician was advancing and retracting a ruby coil through the px slim, the coil unintentionally detached within the px slim.The detached ruby coil was flushed out of the px slim with saline.While attempting to advance a second ruby coil through the px slim, the physician met resistance and the coil would not advance through the entire length of the px slim.Therefore, both the ruby coil and px slim were removed.The procedure was then completed using new ruby coils and a new px slim.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: 5668492
• Report Number: 3005168196-2016-00693
• Device Sequence Number: 166901
• Product Code: HCG
• UDI-Device Identifier: 00814548013039
• UDI-Public: 00814548013039
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/21/2016

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: 03/31/2023
• Device Catalogue Number: RBY2C1440-A
• Device Lot Number: F63000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2016
• Initial Report FDA Received Date: 05/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR