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

Catalog Number	RBY4C0620
Medical Device Problem Codes	Detachment Of Device Component (1104); Kinked (1339); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was fractured approximately 48.5 cm from the proximal end.The embolization coil was detached from its pusher assembly.The proximal constraint sphere was intact on the proximal end of the embolization coil.Conclusions: evaluation of the returned device revealed that the ruby coil¿s pusher assembly was fractured.This type of damage typically occurs due to improper handling during use.If the device is forcefully advanced against resistance, the pusher assembly may become kinked.Upon retracting the kinked pusher assembly, the pusher assembly may come fractured.If the two fractured segments of the pusher assembly are separated during the retraction, the pull wire may retract out of the distal detachment tip (ddt) and allow the embolization coil to detach from its pusher assembly.The resistance experienced by the physician could not be determined.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation.Penumbra coils are visually 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 using ruby coil.During the procedure, the physician experienced resistance while advancing a ruby coil through the end of the non-penumbra microcatheter and into the existing coil mass within the patient; consequently the ruby coil pusher assembly became kinked and the ruby coil unintentionally detached within the microcatheter.The physician therefore removed the microcatheter with the detached coil inside, and then completed the procedure using the same microcatheter and a new 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: 6521037
• Report Number: 3005168196-2017-00656
• Device Sequence Number: 808856
• Product Code: HCG
• UDI-Device Identifier: 00814548013183
• UDI-Public: 00814548013183
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/30/2017

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: 10/02/2024
• Device Catalogue Number: RBY4C0620
• Device Lot Number: F71903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2017
• Initial Report FDA Received Date: 04/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR