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

Catalog Number	RBY4C1650
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2019
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 numbers: 3005168196-2019-02105; 3005168196-2019-02107.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, while advancing a ruby coil through the lantern, the physician reported that the ruby coil was not advancing smoothly.Subsequently, the pusher assembly of the ruby coil became bent, and while pulling back and advancing the ruby coil, the physician felt the ruby coil unintentionally detach in the lantern.Therefore, the physician decided to flush it using a 3cc syringe, but it would not advance further.Therefore, the lantern containing the detached ruby coil was removed and the ruby coil was flushed out.After removal, the distal end of ruby coil was noticed to be damaged.The physician then continued the procedure using additional ruby coils.While advancing another ruby coil through the lantern, the ruby coil became stuck in the aortic portion of the lantern.Subsequently, the pusher assembly of the ruby coil became bent, and the ruby coil unintentionally detached inside the lantern when the physician was pulling back and advancing the ruby coil.Therefore, the lantern containing the detached ruby coil was removed and the physician attempted to flush the coil out of the lantern using a 3cc syringe; however, the ruby coil remained inside the lantern.The procedure was completed using additional ruby coils and another microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the proximal constraint sphere was not present on the proximal end of the embolization coil.The stretch resistant (sr) wire was fractured.Offset coil winds were present throughout the coil.Conclusions: evaluation of the first returned ruby coil revealed that the sr wire was fractured, and the embolization coil was stuck within the returned lantern.This type of damage typically occurs if the device is forcefully retracted against resistance.If the sr wire fractures, the embolization coil will detach from its pusher assembly.Further evaluation revealed offset coil winds.These damages were likely incidental to the complaint.Evaluation of the second returned ruby coil revealed a fractured sr wire.This type of damage typically occurs if the device is forcefully retracted against resistance.If the sr wire fractures, the embolization coil will detach from its pusher assembly.Further evaluation revealed offset coil winds.These damages were likely incidental to the complaint.Evaluation of the returned lantern revealed a distal ovalization.If the distal tip of the device is forcefully pinched or gripped, damage such as a distal ovalization may occur.This damage likely contributed to the resistance experienced during advancement of the ruby coils during the procedure.Further evaluation reveled kinks and an additional ovalization on the lantern.These damages were likely incidental the reported complaint.Penumbra coils and catheters 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.This report is associated with mfr report numbers: 1.3005168196-2019-02105, 2.3005168196-2019-02107.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9307112
• Report Number: 3005168196-2019-02106
• Device Sequence Number: 19333565
• Product Code: HCG
• UDI-Device Identifier: 00814548013244
• UDI-Public: 00814548013244
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2019
• 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: 12/04/2025
• Device Catalogue Number: RBY4C1650
• Device Lot Number: F80880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/17/2019
• Supplement Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 11/11/2019
• Supplement Report FDA Received Date: 12/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Date Report Sent to FDA: 01/01/2005