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

Catalog Number	RBY2C0930
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	06/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the ruby coil pusher assembly was damaged in multiple locations along its length.Conclusions: evaluation of the returned pusher assemblies revealed excessive kink damage along the length of each pusher.These damages were likely incidental and likely occurred during packaging for return.Due to the return packaging-related damage to each of the devices, the root cause of the reported failure could not be determined.However, if an rhv is not used, the introducer sheath may not remain properly aligned within the microcatheter hub.If an embolization coil is advanced while the introducer sheath is not properly aligned, offset coils winds may result.These offset coil winds may contribute to any resistance experienced or the inability to advance the coil into the microcatheter.The lantern mentioned in the complaint and the ruby coil embolization coils were not returned for evaluation.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.This report is associated with mfr report numbers: 3005168196-2017-01149, 3005168196-2017-01150.
Event or Problem Description
The patient was undergoing a coil embolization procedure using pod8's and ruby coils.During the procedure, while attempting to advance a pod8 and two ruby coils out of their introducer sheaths and into the lantern delivery microcatheter (lantern), the technologist encountered resistance and was unable to advance the coils out of their introducer sheaths.Therefore, the pod8 and ruby coils were 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: 6704512
• Report Number: 3005168196-2017-01151
• Device Sequence Number: 19349127
• Product Code: HCG
• UDI-Device Identifier: 00814548012995
• UDI-Public: 00814548012995
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 06/13/2017

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: 03/07/2025
• Device Catalogue Number: RBY2C0930
• Device Lot Number: F74856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2017
• Initial Report FDA Received Date: 07/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR