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

Catalog Number	RBY2C0520
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 74.0 cm from the proximal end.The stretch resistant wire (sr wire) was fractured, the proximal constraint sphere was missing from the distal detachment tip (ddt) and the embolization coil was detached from its pusher assembly.Evaluation of the first evaluated ruby coil revealed that the 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.Further evaluation revealed the sphere was missing from the distal detachment tip (ddt).This may have been due to the pusher assembly elongating which would allow the pull wire to retract from the ddt.However, since the sr wire is fracture this likely occurred after the coil detachment.The root cause of resistance could not be determined.Evaluation of the second evaluated ruby coil revealed that the pusher assembly was fractured.If the device is forcefully advanced against resistance, damage such as a kink may occur.If the kink is further manipulated or straightened, damage such as a fracture may occur.The root cause of resistance could not be determined.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.This report is associated with mfr report number: 3005168196-2018-00818.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right middle lobe segment of the pulmonary artery using ruby coils.During the procedure, a ruby coil prematurely detached within the microcatheter, and therefore the microcatheter was removed with the ruby coil inside.The physician then inserted a new non-penumbra microcatheter, and attempted to place another ruby coil, however the ruby coil was unable to deploy.The ruby coil was therefore removed, and the procedure was completed using the same microcatheter and additional ruby coils.Although there was no report of an adverse effect on the patient, multiple attempts have been made to gather additional information for the second ruby coil.As of (b)(6) 2018, no additional information is available.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7446115
• Report Number: 3005168196-2018-00817
• Device Sequence Number: 19136750
• Product Code: HCG
• UDI-Device Identifier: 00814548012902
• UDI-Public: 00814548012902
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 03/21/2018

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: 06/22/2023
• Device Catalogue Number: RBY2C0520
• Device Lot Number: F64541
• 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: 03/21/2018
• Initial Report FDA Received Date: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42