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

Catalog Number	RBY2C0825
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2018-02070.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left renal artery using a lantern delivery microcatheter (lantern) and ruby coils.During the procedure, the physician experienced resistance while advancing a ruby coil within the lantern and, therefore, the physician retracted the ruby coil.However, while retracting the ruby coil, it unintentionally detached.The physician then advanced a guidewire through the lantern and confirmed the detached ruby coil was still within the lantern.Therefore, the physician removed the lantern with the detached ruby coil inside from the patient.The procedure was completed using a new lantern and new ruby coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the ruby coil was stuck inside the ovalized section of the lantern.The ruby coils stretch resistance wire (sr wire) was fractured and the proximal constraint sphere was missing.Conclusion: evaluation of the returned lantern revealed that the distal tip of the microcatheter was ovalized.If the peel-able sheath (supplied by penumbra) is not used during insertion of the microcatheter into another device, and the distal tip of the microcatheter is forcefully pinched or gripped during insertion, damage such as ovalization may occur.Further evaluation revealed that the ruby coil was stuck inside the catheter shaft of the returned lantern and the sr wire was fractured.If the ruby coil is forcefully advanced into and ovalized catheter, resistance may occur and the coil may become stuck.Subsequently, if the ruby coil is retracted against resistance, damage such as sr wire fracture may occur.The ovalization in the lantern likely contributed to the reported resistance and the ruby coil sr wire fracture.The pusher assembly to the ruby coil was not returned for evaluation and, therefore, the root cause of the ruby coil detachment from its pusher assembly could not be determined.Penumbra coils and catheters 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: 3005168196-2018-02070.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7980598
• Report Number: 3005168196-2018-02071
• Device Sequence Number: 16481999
• Product Code: HCG
• UDI-Device Identifier: 00814548012971
• UDI-Public: 00814548012971
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2018
• 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: 11/11/2025
• Device Catalogue Number: RBY2C0825
• Device Lot Number: F80522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Date Report Sent to FDA: 01/01/2005