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

Model Number	RBY4C1650-A
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2020
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.This report is associated with mfr report number: 3005168196-2020-00692.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using a ruby coil and a lantern delivery microcatheter (lantern).It was noted that the patient anatomy was tortuous.During the procedure, while advancing the ruby coil through the lantern, the ruby coil unintentionally detached inside the lantern; therefore, the lantern containing the detached ruby coil was removed.The procedure was completed using new ruby coils and a new 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.Bends were present along the pusher assembly.The pull wire was within the pusher assembly distal detachment tip (ddt) alignment feature.The proximal constraint sphere was within the ddt.The stretch resistance wire (sr wire) was fractured and offset coil winds were present throughout the length of the embolization coil.Conclusions: evaluation of the returned ruby coil confirmed a detached embolization coil due to a fractured sr wire.If the device is forcefully retracted against resistance, damage such as a fractured sr wire may occur.Further evaluation revealed pusher assembly kinks and offset coil winds coil winds throughout the length of the embolization coil.These damages were likely incidental to the reported complaint.Evaluation of the returned lantern revealed an undamaged and functional device.During functional testing, a demonstration ruby coil was advanced and retracted through the lantern without an issue.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 number: 1.3005168196-2020-00692 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: 10099637
• Report Number: 3005168196-2020-00691
• Device Sequence Number: 11665414
• Product Code: HCG
• UDI-Device Identifier: 00814548013244
• UDI-Public: 00814548013244
• 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
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2020
• Report Date (Section F): 01/01/2005

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RBY4C1650-A
• Device Catalogue Number: RBY4C1650
• Device Lot Number: F93112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/08/2020
• Supplement Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 05/28/2020
• Supplement Report FDA Received Date: 06/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Date Report Sent to FDA: 01/01/2005