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

Model Number RBY2C0840-A

Device Problems Break (1069); Premature Separation (4045)

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

Event Date 05/07/2021

Event Type  Injury  

Manufacturer Narrative

This device is available for return.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 renal artery using ruby coils.During the procedure, the physician implanted three ruby coils in the target location.The next ruby coil was determined to be too long, and the physician decided to remove the ruby coil.When removing the ruby coil, the ruby coil unintentionally detached partially in the renal artery and partially in the aorta.The ruby coil was snared and subsequently broke in half.The physician was then able to snare the remaining coil and removed it from the patient.No additional information regarding the completion of the procedure was provided.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned ruby coil embolization coil confirmed that the coil was detached, fractured, and unraveled.If the ruby coil is forcefully retracted against resistance, damage such as a sr wire fracture may occur.If the sr wire fractures, the embolization coil will become detached and may unravel.Based on the returned condition, the root cause of the resistance could not be determined.Further evalution of the device revealed that the embolization coil was fractured.This damage was likely incidental to the complaint and may have occurred during removal of the embolization coil form the patient body.Penumbra coils are 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.H3 other text : placeholder.

• Brand Name: RUBY COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11930567
• MDR Text Key: 254056460
• Report Number: 3005168196-2021-01231
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548012988
• UDI-Public: 00814548012988
• Combination Product (y/n): Y
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RBY2C0840-A
• Device Catalogue Number: RBY2C0840
• Device Lot Number: F79809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 05/07/2021
• Initial Date FDA Received: 06/03/2021
• Supplement Dates Manufacturer Received: 07/16/2021
• Supplement Dates FDA Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR