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

Model Number	RBY2C1460-A
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2019
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 numbers: 3005168196-2019-02168; 3005168196-2019-02169; 3005168196-2019-02171.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils, pod packing coils (pod pcs) and a ruby coil detachment handle (handle).During the procedure, the physician encountered resistance while advancing a ruby coil through the non-penumbra microcatheter.Subsequently, the ruby coil unintentionally detached within the microcatheter.The microcatheter was then removed from the patient and the detached ruby coil was flushed out.The physician continued the procedure by re-advancing the same microcatheter and another ruby coil into the target vessel.While attempting to detach the ruby coil using the handle, the physician realized that the proximal end of the pusher assembly was stuck in the handle.However, the physician was able to detach and implant the ruby coil into the target vessel after clicking the handle approximately 2-3 times.It was reported that the pusher assembly remained stuck in the handle; therefore, the handle was removed from the procedure.Upon advancing the next pod pc into the microcatheter, the pusher wire became kinked.Therefore, the pod pc was removed.The procedure was completed using a new handle and another ruby coil.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the proximal end of the pusher assembly was fractured and found inside the body of the handle.Conclusions: evaluation of the returned handle revealed that the nosecone was damaged and out of specification.If the proximal end of the pusher assembly is forcefully advanced into the nose cone, damage such as this may occur.Subsequently, if the pusher assembly becomes fractured during detachment using a handle and the handle is continuously actuated, the nosecone may sustain more damage as the proximal end of the pusher assembly is pulled through the nosecone.Evaluation of the first ruby coil confirmed a detached embolization coil and revealed that the ddt was fractured off the distal tip of its pusher assembly.If the ruby coil is manipulated against resistance, damage such as a fractured ddt may occur.If the ddt fractures, the embolization coil will become detached.The non-penumbra microcatheter identified in the complaint was not returned for evaluation, and therefore, the root cause of resistance could not be determined.Evaluation of the pod pc confirmed that the pusher assembly was kinked.This type of damage typically occurs due to forceful advancement against resistance.Further evaluation of the returned pod pc revealed that the sr wire was fractured, and the embolization coil was detached within its introducer sheath.If the ruby coil was retracted against resistance, damage such as these may occur.The non-penumbra microcatheter identified in the complaint was not returned for evaluation, and therefore, the root cause of resistance could not be determined.Evaluation of the second ruby coil confirmed that the proximal end of the pusher assembly was fractured, and the fractured segment was inside the handle body.If the ruby coil pusher assembly is forcefully manipulated during use, damage such as a fracture may occur.The fractured segment being stuck within the handle likely occurred due to multiple actuations of the handle, after the pusher assembly became fractured.Penumbra coils and handles 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 numbers: 3005168196-2019-02168 3005168196-2019-02169 3005168196-2019-02171.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9365723
• Report Number: 3005168196-2019-02170
• Device Sequence Number: 2525022
• Product Code: HCG
• UDI-Device Identifier: 00814548013046
• UDI-Public: 00814548013046
• Combination Product (Y/N): Y
• Initial Reporter Country: SN
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2019
• 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 Model Number: RBY2C1460-A
• Device Catalogue Number: RBY2C1460
• Device Lot Number: F86898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 78
• Date Report Sent to FDA: 01/01/2005