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

Model Number RBY4C1035-B

Device Problems Break (1069); Failure to Fold (1255); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2020

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2020-011611.

Event Description

The patient was undergoing a coil embolization procedure in the subclavian artery using ruby coils, pod packing coils (pod pcs), and a lantern delivery microcatheter (lantern).It was reported that the patient anatomy was calcified.During the procedure, the physician advanced a ruby coil to the target vessel using the lantern and attempted to form the ruby coil back and forth, but the ruby coil did not form well.Subsequently, the physician decided to remove the ruby coil to soak it in saline.As the ruby coil was withdrawn from the lantern and into the introducer sheath, the physician experienced slight resistance.Once on the back table, upon flushing the ruby coil out of the introducer sheath, the ruby coil detached from the pusher assembly.Therefore, the ruby coil was not used for the remainder of the procedure.The physician continued with the procedure and implanted three ruby coils in the target vessel.While advancing the next coil, a pod pc, approximately 10 cm to 20 cm into the lantern, the physician experienced resistance.Therefore, the pod pc was removed.The procedure was completed using another ruby coil and the same lantern.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the pet lock was broken on the proximal end of the pusher assembly.The pusher assembly was kinked in multiple locations.The embolization coil was detached from its pusher assembly and the pull wire was distal to the distal detachment tip (ddt).Conclusions: evaluation of the returned ruby coil confirmed that the embolization coil was detached from its pusher assembly.Further evaluation revealed that the pet lock was broken.If this occurs, the embolization coil will likely detach from its pusher assembly.Further evaluation of the returned ruby coil revealed kinks along the length of the pusher assembly.This damage was likely incidental to the reported complaint.Evaluation of the returned pod pc revealed a fractured pusher assembly and a detached embolization coil.If the pod pc is forcefully advanced against resistance, damage such as a kink may occur.Further manipulation of a kinked pusher assembly may worsen to a fracture.If the fractured segments are separated, the pull wire may be retracted out of the ddt and the embolization coil will likely detach from its pusher assembly.This damage is likely incidental to the reported complaint.Based on the returned condition of the pod pc, the root cause of the reported complaint could not be determined.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: 3005168196-2020-01161.

• Brand Name: RUBY COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10382986
• MDR Text Key: 202199659
• Report Number: 3005168196-2020-01160
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548018669
• UDI-Public: 00814548018669
• Combination Product (y/n): Y
• PMA/PMN Number: K173614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RBY4C1035-B
• Device Catalogue Number: RBY4C1035
• Device Lot Number: F87018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1