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

Catalog Number RBY4C0835

Device Problems Physical Resistance/Sticking (4012); Premature Separation (4045)

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

Event Date 02/09/2024

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.

Event Description

The patient was undergoing a coil embolization procedure in the left subclavian artery using ruby coils, a packing coil (pc), and a non-penumbra microcatheter.It should be noted that the patient¿s anatomy was mildly tortuous.During the procedure, the physician successfully implanted three ruby coils and one pc into the target vessel using the microcatheter.While advancing another ruby coil through the proximal length of the microcatheter, the physician experienced resistance and the ruby coil would not advance any further.While attempting to remove the ruby coil, the coil unintentionally detached within the microcatheter.Therefore, the microcatheter containing the detached ruby coil was removed.It was reported that the ruby coil was flushed out of the microcatheter.The procedure was completed using a new ruby coil and the same microcatheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned ruby coil confirmed that the embolization coil was detached.Evaluation revealed that the pet lock was separated on the proximal end of the pusher assembly, the pull wire was retracted out of the distal tip of the pusher assembly.If this occurs, the embolization coil will detach from its pusher assembly.This typically occurs during a successful detachment attempt, and therefore, the root cause of the reported complaint cannot be determined.Further evaluation revealed kinks along the length of the pusher assembly and the detached embolization had offset coil winds along its length.This damage was incidental to the reported complaint and may have occurred during packaging of the device for return to penumbra.Due to the returned condition, the ruby coil was unable to be functionally tested.Therefore, the root cause of the reported resistance during the procedure 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.

• 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: 18984110
• MDR Text Key: 339221224
• Report Number: 3005168196-2024-00108
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548018386
• UDI-Public: 814548018386
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RBY4C0835
• Device Lot Number: F00001749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2024
• 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: 03/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2022
• 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