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

Catalog Number	RBY2C0620-A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the coil was detached from the ruby coil pusher assembly.The stretch resistant (sr) wire of the coil was fractured, and the proximal constraint sphere was missing.Conclusions: evaluation of the returned device revealed that the embolization coil sr wire was fractured.This type of damage typically occurs due to improper handling during use.If the ruby coil is forcefully retracted against resistance, this type of damage may occur.An sr wire fracture will likely lead to an unintentional detachment.Neither the px slim, nor the ruby coil pusher assembly was returned for evaluation and, therefore, the cause of the resistance could not be determined.Penumbra coils are 100% visually and functionally evaluated during inspection.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 coils.During the procedure, the physician advanced a ruby coil through a px slim delivery microcatheter (px slim) and decided to retract it in order to reposition the tip of the px slim.While retracting the ruby coil, it unintentionally detached in the px slim.The physician removed the px slim from the patient and pushed out the ruby coil.The procedure was completed using a new ruby coil with the same 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: 5461654
• Report Number: 3005168196-2016-00241
• Device Sequence Number: 18982800
• Product Code: HCG
• UDI-Device Identifier: 00814548012933
• UDI-Public: 00814548012933
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 01/28/2016

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: 09/20/2023
• Device Catalogue Number: RBY2C0620-A
• Device Lot Number: F65774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR