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

Catalog Number	RBY2C0305
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was separated, pull wire retracted from the distal detachment tip (ddt), and the embolization coil was detached.The proximal constraint sphere was intact with the embolization coil.There was noticeable blood within the pusher assembly.Conclusions: evaluation of the returned ruby coil revealed the pet lock was separated, pull wire retracted from the ddt, and the embolization coil was detached.Further evaluation revealed a significant amount of blood within the pusher assembly.This blood may have coagulated around the proximal constraint sphere and ddt contributing to the difficulty detaching the embolization coil.If continuous flush is not used, blood may backflow and coagulate on the device.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.This report is associated with mfr report number: 3005168196-2018-00967.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using ruby coils and a ruby coil detachment handle (handle).During the procedure, the physician was unable to detach the ruby coil, despite the pet lock being broken after using the handle.The ruby coil was therefore removed and the procedure was completed using a new ruby coil and the same handle.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: 7495254
• Report Number: 3005168196-2018-00966
• Device Sequence Number: 10846239
• Product Code: HCG
• UDI-Device Identifier: 00814548012810
• UDI-Public: 00814548012810
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 04/11/2018

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: 04/19/2025
• Device Catalogue Number: RBY2C0305
• Device Lot Number: F75787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 05/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1