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

Catalog Number RBY4C0630

Device Problems Break (1069); Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Results: the embolization coil stretch resistance wire (sr wire) was fractured for the evaluated ruby coil.Conclusions: evaluation of the podj and pod5 confirmed that their pusher assemblies were kinked.This damage was likely accidental by the hospital staff as mentioned in the complaint.Further evaluation of the pod5 revealed that the pusher assembly was fractured.This damage likely occurred from the initial kink in the pusher assembly being straightened during manipulation, which resulted in the pod5 pusher assembly fracturing.Evaluation of the returned ruby coil revealed that the sr wire was fractured.This type of damage typically occurs when the device is forcefully retracted against resistance.The fractured sr wire likely resulted in the unintentional detachment.Due to the ruby coil pusher assembly not returning for evaluation, the root cause of the sr wire fracture could not be determined.The lantern delivery microcatheters (lanterns) mentioned in the complaint and ruby coil¿s pusher assembly were 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 numbers: 3005168196-2017-02328, 3005168196-2017-02329.

Event Description

The patient was undergoing a coil embolization procedure in the splenic artery using pod packing coils (podjs), pod5s, and ruby coils.During the procedure, the hospital staff accidently kinked the pusher wires of a podj and a pod5 while attempting to advance the coils into a lantern delivery microcatheter (lantern).The podj and pod5 were therefore removed.The physician then attempted to place a ruby coil using the lantern, however did not like how the coil was forming within the patient.The physician therefore attempted to retract the ruby coil, however accidentally retracted the lantern and sheath as well.The physician therefore re-advanced the lantern and sheath into the target location, and as the physician re-attempted to advance the same ruby coil, it unintentionally detached.The physician therefore removed the lantern with the ruby coil inside, and once it was outside of the patient, it was found that the ruby coil had broken in to two pieces.Both of the pieces were outside of the patient, and therefore the procedure continued and was completed using additional podjs and ruby coils.During the procedure, three different lanterns were used because the physician needed different tip shapes, and also because the physician believed new lanterns might be more stable.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: 7155437
• MDR Text Key: 96114744
• Report Number: 3005168196-2017-02330
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013190
• UDI-Public: 00814548013190
• 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: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: RBY4C0630
• Device Lot Number: F61941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/26/2014
• 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: 37