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

Catalog Number	RBY2C1260
Medical Device Problem Codes	Break (1069); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/29/2019
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 product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report numbers: 3005168196-2019-01047, 3005168196-2019-01048.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the inferior mesenteric artery (ima) and the internal iliac artery (iia) using ruby coils and pod5s.It should be noted that the patient's anatomy was tortuous.During the procedure, the first ruby coil was advanced into the ima using a lantern delivery microcatheter (lantern), but would not take shape in the vessel.The ruby coil was therefore removed and not used in the procedure.The physician attempted to advance a pod5; however, the pod5 was unable to advance out of the rotating hemostasis valve (rhv)and into the lantern and was therefore removed.Another pod5 was then implanted successfully in the ima using the same lantern.The physician advanced another ruby coil into the iia and made several attempts to reposition it within the vessel.While retracting the ruby coil into the lantern during an attempt to reposition, the ruby coil unintentionally detached and broke into two pieces.It was noted that one piece of the ruby coil broke off in the patient's vessel and another piece broke off inside the lantern.The lantern and piece of the ruby coil were removed together from the patient and a snare was used to retrieve the remaining piece of ruby coil from the patient's vessel.The procedure was then terminated and the patient was discharged.There was no report of an adverse effect to the patient.It was reported that the patient returned for another procedure on (b)(6) 2019.During this procedure, the ima and iia embolization was completed using another ruby coil and two pod packing coils (pod pcs).There was no report of an adverse effect to the patient.
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:3005168196-2019-01049.1.Section h.Box 6.Method code.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8646304
• Report Number: 3005168196-2019-01049
• Device Sequence Number: 19301816
• Product Code: HCG
• UDI-Device Identifier: 00814548013022
• UDI-Public: 00814548013022
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2019
• 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 Catalogue Number: RBY2C1260
• 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: 04/29/2019
• Supplement Date Received by Manufacturer: 04/29/2019
• Initial Report FDA Received Date: 05/28/2019
• Supplement Report FDA Received Date: 05/28/2019
• 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
• Patient Weight: 93
• Date Report Sent to FDA: 01/01/2005