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

Model Number	RBY2C2457-B
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2021
Type of Reportable Event	Malfunction
Additional 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: 3005168196-2021-01593.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the renal artery using ruby coils, a lantern delivery microcatheter (lantern), a non-penumbra stent, a non-penumbra catheter, and a guidewire.It was noted that the patient anatomy was tortuous.During the procedure, the physician placed a stent in the target vessel.The physician then placed the microcatheter through the stent and when advancing a ruby coil as the first coil, the physician experienced resistance in the distal end of the lantern.Therefore, the physician decided to remove the ruby coil and lantern.However, while retracting, it was noticed that the ruby coil had unintentionally detached inside the lantern.Subsequently, upon removal, it was noted that the lantern was ovalized approximately two centimeters from the distal tip.The procedure was completed using six new ruby coils and a new lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil revealed that the ddt was fractured off the distal polymer of the pusher assembly, and the embolization coil was detached.If the ruby coil is forcefully manipulated against resistance, damage such as this may occur.The ovalization in the returned lantern likely contributed to the resistance during the procedure.Further evaluation revealed kinks and bent throughout the length of the pusher assembly.This damage was incidental to the reported complaint and likely occurred due to the forceful manipulation against resistance.Evaluation of the returned lantern confirmed that the catheter was ovalized and revealed that the ruby coils embolization coil was inside the ovalized location.The patient tortuous anatomy may have contributed to the ovalization.This damage likely contributed to the reported resistance during the procedure.Penumbra devices 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: 3005168196-2021-01593 h3 other text : placeholder.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12188779
• Report Number: 3005168196-2021-01592
• Device Sequence Number: 19202481
• Product Code: HCG
• UDI-Device Identifier: 00814548019291
• UDI-Public: 00814548019291
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/10/2026
• Device Model Number: RBY2C2457-B
• Device Catalogue Number: RBY2C2457
• Device Lot Number: F92426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/20/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Date Report Sent to FDA: 01/01/2005