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

Catalog Number	RBY2C0312
Medical Device Problem Codes	Detachment Of Device Component (1104); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a small branch in a pulmonary arteriovenous malformation (pavm) using ruby coils.During the procedure, while attempting to advance a ruby coil through a non-penumbra microcatheter, the physician experienced resistance and subsequently, the ruby coil unintentionally detached within the microcatheter.Therefore, the physician removed the microcatheter containing the detached coil.The procedure was then completed using a new ruby coil and a new microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The ruby coil embolization coil was initially stuck inside the ovalized region of the non-penumbra microcatheter, but was later flushed out by a penumbra investigator.The ruby coil stretch resistant wire (sr wire) was then revealed to be fractured.Evaluation of the returned device revealed that the non-penumbra microcatheter was ovalized.Further evaluation of the returned device revealed that the ruby coil sr¿s wire was fractured.This type of damage typically occurs due to improper handling during use.If the device is forcefully retracted against resistance, fracture of the sr wire may occur, which will cause detachment of the embolization coil.The ovalization in the non-penumbra microcatheter likely contributed to the resistance encountered during advancement of the ruby coil through the non-penumbra microcatheter.The ruby coil's pusher assembly 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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6691232
• Report Number: 3005168196-2017-01119
• Device Sequence Number: 16154874
• Product Code: HCG
• UDI-Device Identifier: 00814548012827
• UDI-Public: 00814548012827
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2017

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: 08/15/2024
• Device Catalogue Number: RBY2C0312
• Device Lot Number: F71147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2017
• Initial Date Received by Manufacturer: 06/08/2017
• Supplement Date Received by Manufacturer: 08/16/2017
• Initial Report FDA Received Date: 07/06/2017
• Supplement Report FDA Received Date: 08/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1