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

Catalog Number	RBY4C0630
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the ruby coil sr wire was fractured and the proximal constraint was detached from the embolization coil.The ruby coil was stretched and contained offset coils.The introducer sheath contained coagulated blood inside.The penumbra investigator attempted to flush the introducer sheath of coagulated blood.The penumbra investigation then successfully removed the embolization coil from the introducer sheath by using a demonstration mandrel to advance the coagulated blood and embolization coil through the introducer sheath.The ruby coil was damaged and the pusher was not returned for evaluation.Conclusions: evaluation of the returned ruby coil revealed a coil detached from the pusher assembly and a fractured sr wire.The introducer sheath was returned with coagulated blood inside.If continuous flush is not used during a procedure, blood may backflow and coagulate on the device.If blood coagulates on the device, it will likely result in difficulty advancing the embolization coil.If a device is forcefully advanced or retracted against resistance, the sr wire may fracture.Penumbra coils are visually 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
During preparation for a coil embolization procedure, the hospital staff removed the ruby coil from the packaging hoop and flushed it.However, when they were trying to re-sheath the ruby coil into the introducer sheath, the embolization coil detached from the pusher assembly.The damage to the ruby coil was found prior to use.Therefore, the ruby coil was not used in the procedure.The procedure was completed using a new ruby coil.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7720655
• Report Number: 3005168196-2018-01448
• Device Sequence Number: 1329629
• Product Code: HCG
• UDI-Device Identifier: 00814548013190
• UDI-Public: 00814548013190
• Combination Product (Y/N): Y
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/28/2018
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/18/2025
• Device Catalogue Number: RBY4C0630
• Device Lot Number: F78264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 07/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005