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

Catalog Number	RBY2C0435
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2019-00512.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, the physician successfully placed four ruby coils using a lantern delivery microcatheter (lantern).The physician then felt resistance and was unable to advance two ruby coils through the lantern and, therefore, the ruby coils were removed.The procedure was then completed using a pod packing coil and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked in multiple locations along its length.The embolization coil was intact with its pusher assembly and had offset coil winds.Conclusions: evaluation of the first and second returned ruby coil revealed multiple kinks along the length of both pusher assemblies.During functional testing, resistance was encountered while attempting to re-sheath both returned ruby coils and the pusher assemblies could not be retracted into their introducer sheaths.Therefore, based on the returned condition, the root cause of the reported advancement issue through a lantern could not be determined.Further evaluation of the second returned ruby coil revealed offset coil winds.This damage likely occurred due to the embolization coil not being protected by an introducer sheath during packaging of the device for return.The lantern identified in the complaint and the introducer sheath to the second evaluated ruby coil were not returned for evaluation.Penumbra coils and catheters 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.Results code 3: 4247 - the investigation did not lead to clear results.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the root cause of the reported advancement issue through the lantern.This report is associated with mfr report number: 1.3005168196-2019-00512.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8437386
• Report Number: 3005168196-2019-00513
• Device Sequence Number: 2227282
• Product Code: HCG
• UDI-Device Identifier: 00814548018614
• UDI-Public: 00814548018614
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• 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): 02/19/2019
• 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: 07/10/2026
• Device Catalogue Number: RBY2C0435
• Device Lot Number: F84615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 05/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Date Report Sent to FDA: 01/01/2005