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

Model Number RBY4C1035-B

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2021

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the returned ruby coil revealed that the pusher assembly was fractured, the embolization coil was detached from the pusher assembly and had offset coil winds.The complaint was confirmed.The probable cause of the reported damage was likely due to advancement against resistance, during use as indicated in the complaint.If the pusher assembly is forcefully advanced against resistance, damage such as a kink and subsequent fracture may occur.The offset coil winds may have contributed to the resistance during the procedure.If the pusher assembly fractures, the embolization coil may detach from the pusher assembly.Further evaluation revealed an additional kink.This damage was incidental to the reported complaint.Penumbra products 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.

Event Description

The patient was undergoing a coil embolization procedure in the subclavian artery using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician experienced resistance after advancing the ruby coil as the first coil past the hub of the lantern.Consequently, the physician broke the pusher assembly and detached the ruby coil inside the lantern.Therefore, the lantern was containing the detached ruby coil was removed and the coil was flushed out.The procedure was completed using a new ruby coil, pod packing coils (pod pc), and the same lantern.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: 12565532
• MDR Text Key: 274457704
• Report Number: 3005168196-2021-02172
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548018669
• UDI-Public: 00814548018669
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K173614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• 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: F94158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Is the Reporter a Health Professional?: Yes
• 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: 09/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2019
• 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