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

Model Number	RBY4C0315-A
Medical Device Problem Codes	Detachment Of Device Component (1104); Retraction Problem (1536); Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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: 3005168196-2018-00325, 3005168196-2018-00326, 3005168196-2018-00327.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) to treat a gastrointestinal (gi) bleed using ruby coils.During the procedure, the physician was unable to advance three ruby coils through a non-penumbra microcatheter, and therefore, the ruby coils were removed.The physician then attempted to advance another ruby coil through the microcatheter, however it became stuck and then unintentionally detached as the physician was attempting to remove it.The physician was unable to place the detached ruby coil, and therefore the microcatheter was removed with the ruby coil inside.The procedure was aborted at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This report is associated with mfr report number: 3005168196-2018-00325, 3005168196-2018-00326, and 3005168196-2018-00327.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7263469
• Report Number: 3005168196-2018-00324
• Device Sequence Number: 16449840
• Product Code: HCG
• UDI-Device Identifier: 00814548013152
• UDI-Public: 00814548013152
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• 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): 01/15/2018
• 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 Expiration Date: 10/08/2025
• Device Model Number: RBY4C0315-A
• Device Catalogue Number: RBY4C0315
• Device Lot Number: F79908
• 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: 01/15/2018
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 02/12/2018
• Supplement Report FDA Received Date: 07/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005