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

Catalog Number	RBY2C3260
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2019
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the native iliac wall using ruby coils.During the procedure, the physician successfully placed a ruby coil in the target vessel using the lantern delivery microcatheter (lantern).While attempting to insert a new ruby coil into the lantern, the pusher wire snapped; therefore, it was removed.The procedure was completed using a new ruby coil with the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was broken at the proximal end of the pusher assembly.The hypotube was fractured approximately 5.0 cm from the proximal end.The pull tube was kinked approximately 8.0 cm from the proximal end.The distal detachment tip (ddt) was undamaged.Conclusion: evaluation of the returned ruby coil pusher assembly confirmed a fractured device.If the device is forcefully advanced against resistance, damage such as a fracture may occur.The pull tube within the hypotube was also kinked which is likely occurred simultaneously with the fracture.Further evaluation revealed the pet lock was broken at the proximal end of the pusher assembly; therefore, it is likely the embolization coil was detached from the ddt prior to the damage to the pusher assembly.Penumbra coils 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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8313432
• Report Number: 3005168196-2019-00200
• Device Sequence Number: 2202763
• Product Code: HCG
• UDI-Device Identifier: 00814548019321
• UDI-Public: 00814548019321
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• 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): 01/08/2019
• 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: 05/05/2026
• Device Catalogue Number: RBY2C3260
• Device Lot Number: F83292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 02/06/2019
• Supplement Report FDA Received Date: 04/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 84
• Date Report Sent to FDA: 01/01/2005