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

Catalog Number	RBY4C0406
Medical Device Problem Codes	Detachment Of Device Component (1104); Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the embolization coil was detached and the proximal constraint sphere was present inside the distal detachment tip (ddt), and the pet lock was intact.The pusher assembly was kinked approximately 5.0 cm from its proximal end.There was clotted blood present inside the sheath.Conclusions: evaluation of the returned pc400 revealed the embolization coil was detached via a stretch resistant (sr wire) fracture.This damage was likely a result of retracting the embolization coil against extreme resistance.The embolization coil and lantern used in the procedure were not returned for evaluation.Therefore, the root cause of the resistance could not be determined.Further evaluation revealed blood present inside the sheath, which may have contributed to resistance experience.A kink was also present on the proximal end of the pusher assembly.This kink was likely incidental and may have occurred during packaging for return to penumbra.Penumbra coils are 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 using ruby coils.During the procedure, while attempting to retract a ruby coil, the ruby coil unintentionally detached within the lantern delivery microcatheter (lantern).Therefore, the physician removed the lantern containing the detached coil and flushed the coil onto the back table.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: 7423576
• Report Number: 3005168196-2018-00761
• Device Sequence Number: 35979
• Product Code: HCG
• UDI-Device Identifier: 00814548013169
• UDI-Public: 00814548013169
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/20/2018

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: 11/20/2025
• Device Catalogue Number: RBY4C0406
• Device Lot Number: F80677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 52