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

Catalog Number	RBY4C0315
Medical Device Problem Codes	Detachment Of Device Component (1104); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Please note the lot numbers for the two complaint coils are f80129 and f80744, however it is unknown which coil had which failure type, therefore both lots were reviewed.The products were not returned for evaluation.Without the return of the devices, the root cause of the problem cannot be determined.The manufacturing records for these lots were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report numbers: 3005168196-2018-00582.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a coil embolization procedure treating a gastrointestinal bleed using ruby coils.During the procedure, the physician advanced and retracted a ruby coil back into its introducer sheath.When attempting to advance the ruby coil later in the procedure, the physician was unable to advance it out of its introducer sheath.Another ruby coil was also retracted back into its introducer sheath, however the ruby coil unintentionally detached upon retraction into the introducer sheath.The procedure was completed using additional ruby coils.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastrointestinal artery using ruby coils.During the procedure, the physician retracted a ruby coil into its introducer sheath after advancing it within the non-penumbra microcatheter because the ruby coil was the wrong size.When attempting to advance the same ruby coil later in the procedure, the physician was unable to advance it out of its introducer sheath.Another ruby coil was also retracted because the physician believed it was the wrong size, however the ruby coil unintentionally detached upon retraction into the introducer sheath.The procedure was completed using additional ruby coils.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7345874
• Report Number: 3005168196-2018-00581
• Device Sequence Number: 18841093
• Product Code: HCG
• UDI-Device Identifier: 00814548013152
• UDI-Public: 00814548013152
• Combination Product (Y/N): Y
• Initial Reporter State: ND
• Initial Reporter Country: US
• 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): 02/23/2018
• 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: Physician
• Device Catalogue Number: RBY4C0315
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/23/2018
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 03/16/2018
• Supplement Report FDA Received Date: 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Date Report Sent to FDA: 01/01/2005