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

Catalog Number	RBY4C1650
Medical Device Problem Codes	Detachment Of Device Component (1104); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2018
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.This report is associated with mfr report number: 3005168196-2018-01098.The device was implanted in the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the inferior mesenteric artery (ima) using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, while advancing a ruby coil through the lantern, the physician experienced resistance and still tried to advance the coil; consequently, the ruby coil unintentionally detached in the patient's ima.The physician thought the lantern was kinked; however, upon removal no kink was observed on the lantern.The majority of the detached ruby coil was left inside the ima; therefore, the physician made multiple attempts to snare the detached ruby coil out; however, the physician was unable to.Therefore, the procedure ended after the physician lost access while trying to advance the snare device and not being able to regain access.The ima seemed patent at the end of the procedure.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Reportable event: serious injury.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7557841
• Report Number: 3005168196-2018-01097
• Device Sequence Number: 2324048
• Product Code: HCG
• UDI-Device Identifier: 00814548013244
• UDI-Public: 00814548013244
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2018

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: 07/23/2025
• Device Catalogue Number: RBY4C1650
• Device Lot Number: C04354
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/09/2018
• Supplement Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 05/31/2018
• Supplement Report FDA Received Date: 05/31/2018
• 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