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

Catalog Number	RBY4C0315
Medical Device Problem Codes	Detachment Of Device Component (1104); Retraction Problem (1536); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2018
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) for a gastrointestinal (gi) bleed using ruby coils and a lantern delivery microcatheter (lantern).It was noted that the patient anatomy was tortuous.During the procedure, the physician successfully deployed and detached several ruby coils using the lantern.The physician deployed a ruby coil and attempted to reposition it; however the physician felt resistance after advancing the ruby coil approximately 2cm out of the lantern.The physician then attempted to retract the ruby coil; however upon retraction, the physician again felt more resistance and the ruby coil unintentionally detached inside of the lantern.The physician therefore removed the lantern with the ruby coil inside.An angiogram was then performed which confirmed all of the coil was removed and the target vessel was sufficiently occluded, and the procedure therefore ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that a correction was made to the following section(s): section b.Box 2.Outcomes attributed to adverse event "congenital anomaly/birth defect" was inadvertently checked.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7249929
• Report Number: 3005168196-2018-00296
• Device Sequence Number: 16178150
• Product Code: HCG
• UDI-Device Identifier: 00814548013152
• UDI-Public: 00814548013152
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/10/2018

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: 07/18/2025
• Device Catalogue Number: RBY4C0315
• Device Lot Number: F78256
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/10/2018
• Supplement Date Received by Manufacturer: 01/10/2018
• Initial Report FDA Received Date: 02/07/2018
• Supplement Report FDA Received Date: 02/14/2018
• 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: Congenital Anomaly
• Patient Age: 79 YR