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

Catalog Number	RBY2C0740
Medical Device Problem Codes	Break (1069); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2019
Type of Reportable Event	Serious Injury
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 a self-expanding stent in the left renal artery using ruby coils.During the procedure, the physician successfully placed 21 ruby coils using a non-penumbra microcatheter.The physician then attempted to place another ruby coil, however, while retracting to reposition it, the ruby coil unintentionally detached.The physician then used a snare device to retract the ruby coil, however, the coil broke while partially retracted out of the hub of the microcatheter.Therefore, the physician was able to pull the ruby coil out of the microcatheter, and the procedure was completed using additional ruby coils and the same microcatheter.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 embolization coil stretch resistant wire (sr wire) was fractured and the constraint sphere and pull wire were within the distal detachment tip (ddt).Conclusions: evaluation of the returned ruby coil revealed the sr wire was fractured and constraint sphere was within the ddt.If the ruby coil was forcefully retracted against resistance, the sr wire may fracture and the embolization coil may detach.The cause of the resistance could not be determined.Based on the reported complaint, some of the embolization coil damage occurred during attempts to retrieve the device.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: 8404090
• Report Number: 3005168196-2019-00427
• Device Sequence Number: 2326690
• Product Code: HCG
• UDI-Device Identifier: 00814548012964
• UDI-Public: 00814548012964
• Combination Product (Y/N): Y
• Initial Reporter Country: SN
• 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): 02/06/2019
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/17/2026
• Device Catalogue Number: RBY2C0740
• Device Lot Number: F81528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Date Report Sent to FDA: 01/01/2005