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

Catalog Number	RBY2C0520-A
Medical Device Problem Codes	Detachment Of Device Component (1104); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/22/2016
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery using ruby coils.During the procedure, upon attempting to deploy a ruby coil in the target vessel using a lantern delivery microcatheter (lantern), the physician realized that the coil used wasn¿t the correct size; therefore, the physician decided to remove it.However, upon retracting the ruby coil, it unintentionally detached and became lost in the patient's body.Due to the patient being distressed, the physician didn¿t have time to snare out the detached ruby coil and the patient was taken to surgery.The physician did not mention any particular resistance prior to the coil unintentional detachment.It should be noted that the physician did not use a rotating hemostasis valve (rhv) and did not use continuous flush.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report.Adverse event and/or product problem.Outcomes attributed to adverse event.If implanted, give date.Type of reportable event.Reason for non-evaluation/''other'' reason for non-evaluation.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6195075
• Report Number: 3005168196-2016-01847
• Device Sequence Number: 10864586
• Product Code: HCG
• UDI-Device Identifier: 00814548012902
• UDI-Public: 00814548012902
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2016
• 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: Physician
• Device Expiration Date: 08/31/2024
• Device Catalogue Number: RBY2C0520-A
• Device Lot Number: F71444
• 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: 11/23/2016
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 12/21/2016
• Supplement Report FDA Received Date: 05/20/2019
• 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
• Date Report Sent to FDA: 01/01/2005