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

Catalog Number RBY4C0835

Device Problems Kinked (1339); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 6.0 and 8.0 cm from the proximal end of the pusher assembly.The embolization coil was intact with its pusher assembly.The embolization coil had offset coil winds.Conclusions: evaluation of the returned ruby coil confirmed the embolization coil was damaged.This type of damage likely occurred due to mishandling while retracting the coil.If the sheath were oriented such that the embolization coil did not have a smooth path of entry while retracting the device it may have contributed to the damage observed on the returned coil.These offset coil winds prevented the ruby coil from being re-sheathed during evaluation.Further evaluation of the returned ruby coil revealed pusher assembly was kinked.This damage was likely incidental to the reported failure and may have occurred during handling post-procedure or during packaging for return.The non-penumbra microcatheter identified in the complaint was not returned to penumbra for evaluation.The root cause of the ruby coil not forming could not be determined.Penumbra coils are visually inspected during in-process 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 Description

The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, the physician retracted and removed a ruby coil from the non-penumbra microcatheter because it was not forming as expected in the target location.The embolization coil then became kinked as the physician was retracting the ruby coil into its introducer sheath on the back table and, therefore, the ruby coil could not be fully re-sheathed.The procedure was completed using a new ruby coil.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7620774
• MDR Text Key: 111906566
• Report Number: 3005168196-2018-01204
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013206
• UDI-Public: 00814548013206
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: RBY4C0835
• Device Lot Number: F74223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 12 YR