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

Catalog Number	RBY4C0204
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the introducer sheath was ovalized distal to the embolization coil.The embolization coil was compressed along its length.Conclusions: evaluation of the returned ruby coil revealed an ovalized introducer sheath.This damage is likely a result of forceful mishandling during preparation for the procedure.Further evaluation revealed compression damage along the length of the embolization coil.This is likely a result of advancing the embolization coil against the resistance created by the ovalized introducer sheath.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.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 left gastric using ruby coils (ruby coils).During the procedure, the physician experienced resistance and was unable to advance a ruby coil into the hub of the lantern delivery microcatheter (lantern).Therefore the ruby coil was removed and the procedure was completed using new ruby coils and the same lantern.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7219051
• Report Number: 3005168196-2018-00208
• Device Sequence Number: 1213334
• Product Code: HCG
• UDI-Device Identifier: 00814548013138
• UDI-Public: 00814548013138
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 12/28/2017

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: 07/12/2025
• Device Catalogue Number: RBY4C0204
• Device Lot Number: F78165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2017
• Initial Report FDA Received Date: 01/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR