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

Model Number	RBY4C1240-A
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	03/05/2020
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.
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).It was noted that the patient anatomy was tortuous.During the procedure, the physician successfully implanted six ruby coils in the target vessel using the lantern.While advancing the seventh ruby coil through the lantern, the physician experienced resistance and decided to retract the ruby coil.While retracting the ruby coil, it unintentionally detached inside the lantern.Therefore, the physician removed the lantern containing the detached ruby coil and then removed the ruby coil.The procedure was completed using three additional ruby coils and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The stretch resistance wire (sr wire) was fractured and the embolization coil was detached from its pusher assembly.Conclusions: evaluation of the returned ruby coil confirmed a detached embolization coil and revealed that the sr wire was fractured.If the ruby coil is forcefully retracted against resistance, damage such as a fractured sr wire may occur.The lantern identified in the complaint was not returned for evaluation, and therefore, the root cause of resistance could not be determined.Penumbra coils 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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9891595
• Report Number: 3005168196-2020-00455
• Device Sequence Number: 2421079
• Product Code: HCG
• UDI-Device Identifier: 00814548013237
• UDI-Public: 00814548013237
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2020
• 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: 09/04/2026
• Device Model Number: RBY4C1240-A
• Device Catalogue Number: RBY4C1240
• Device Lot Number: F85719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 06/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 80
• Date Report Sent to FDA: 01/01/2005