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

Catalog Number	RBY2C0530
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/16/2018
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 kinked approximately 5.0 cm from the proximal end.The embolization coil was detached from its pusher assembly.The stretch resistant wire (sr wire) was fractured and the proximal constraint sphere was inside the distal detachment tip (ddt).Conclusions: evaluation of the returned device revealed that the ruby coils sr wire was fractured.This type of damage typically occurs due to improper handling during use.If the device is forcefully retracted against resistance, damage such as this may occur.The fracturing of the sr wire likely contributed to the ruby coil detachment inside the catheter.Further evaluation of the returned device revealed that the pusher assembly was kinked.This kink was likely incidental and may have occurred while packaging the device for return to penumbra.The non-penumbra microcatheter referred to 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 in the left internal mammary artery (lima) using ruby coils.During the procedure, while attempting to advance a ruby coil through a non-penumbra catheter the physician noticed that the ruby coil unintentionally detached inside the catheter.Therefore, the physician removed the catheter containing the detached ruby coil and the procedure was completed using other coils and a new catheter.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: 7334339
• Report Number: 3005168196-2018-00549
• Device Sequence Number: 270540
• Product Code: HCG
• UDI-Device Identifier: 00814548012919
• UDI-Public: 00814548012919
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2018

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: 03/13/2025
• Device Catalogue Number: RBY2C0530
• Device Lot Number: F74981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 03/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 YR