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

Catalog Number RBY4C0860-A

Device Problems Kinked (1339); Premature Activation (1484); Difficult to Remove (1528); Device Slipped (1584); Sticking (1597); Unraveled Material (1664)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/17/2015

Event Type  malfunction  

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the ruby coil pusher assembly.The pusher assembly was kinked throughout its length and the proximal constraint sphere was contained within the distal detachment tip (ddt).The introducer sheath was kinked throughout its length.The embolization coil was detached from the pusher assembly and unraveled due to a fractured stretch resistant (sr) wire.Conclusions: evaluation of the first ruby coil revealed the pusher assembly was not returned and the embolization coil was detached.Since the pusher assembly was not returned, the root cause of the pusher assembly becoming kinked could not be determined.Evaluation of the second ruby coil revealed the stretch resistant (sr) wire was fractured and the embolization coil was detached.This type of damage typically occurs due to forcefully withdrawing the ruby coil against resistance.Further evaluation revealed that the pusher assembly of the second ruby coil and the introducer sheaths of both devices were damaged throughout their lengths.This damage was likely due to return packaging conditions, as both ruby coils were folded and entangled within the specimen bag.Ruby coils are 100% functionally evaluated during in-process inspection.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: 3005168196-2016-00054.

Event Description

The patient was undergoing a coil embolization procedure in the ovarian vein using ruby coils.During the procedure, the physician successfully deployed and detached a pod4 coil, a pod6 coil and two ruby coils into the aneurysm using a lantern microcatheter (lantern).While advancing a new a ruby coil through the lantern, the ruby coil pusher assembly became kinked and the coil was removed.While advancing a new ruby coil out of the lantern and into the aneurysm, the ruby coil slipped back into its guide catheter and became lodged into the guide catheter.The physician attempted to remove the ruby coil; however, it unintentionally detached inside the lantern.The physician removed the lantern and the ruby coil was left inside the guide catheter.As the physician started pulling the ruby coil out from the proximal end, it started to unravel a bit but then the rest of the coil came out intact.The physician performed an angiogram and confirmed that the target vessel embolized as intended.The procedure was completed and 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 (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5371641
• MDR Text Key: 36500678
• Report Number: 3005168196-2016-00055
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013213
• UDI-Public: 00814548013213
• 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: Other
• Type of Report: Initial
• Report Date: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/18/2023
• Device Catalogue Number: RBY4C0860-A
• Device Lot Number: F66084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2015
• 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: 47 YR