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

Catalog Number	RBY2C1857
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	11/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet locks was intact on the proximal end of the first evaluated ruby coil.The introducer sheath was ovalized approximately 7.0 cm from the distal tip of the introducer sheath on the first ruby coil evaluated.The embolization coil for the first ruby coil was intact with its pusher assembly.The outer diameter (od) of the embolization coil to the first evaluated ruby coil was measured to be within specification.Conclusions: evaluation of the first ruby coil revealed that the introducer sheath was ovalized.This type of damage typically occurs due to improper handling during use.If the rotating hemostasis valve (rhv) is overtightened during use, damage such as ovalization to the introducer sheath may occur for the first ruby coil evaluated.The od of the embolization coil was measured to be within specification.The first evaluated ruby coil was advanced through a demonstration microcatheter; resistance was encountered as the proximal end of the embolization coil passed through the ovalization in the introducer sheath.The ruby coil was advanced completely through the demonstration microcatheter and out of the distal tip.The ovalization in the introducer sheath likely contributed to the resistance experience during procedure.Evaluation of the second returned ruby coil revealed that the proximal end of the introducer sheath was ovalized.This type of damage typically occurs due to improper handling during use.If the introducer sheath is forcefully handled during use, damage such as ovalization may occur.The returned ruby coil could not be advanced out of its introducer sheath and through a demonstration microcatheter during the functional test.The root cause of the reported resistance could not be determined.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.This report is associated with mfr report number: 3005168196-2017-02097.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils.During the procedure, the physician used a lantern delivery microcatheter (lantern) to deploy and detach multiple ruby coils to the target location.The physician then switched to a new lantern with a different tip shape to continue the procedure.The physician successfully deployed and detached a ruby coil using the lantern; then felt resistance while advancing two new ruby coils more than two thirds of the way through the lantern.The ruby coils were therefore removed, and the procedure was completed using additional ruby coils and pod coils.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: 7065576
• Report Number: 3005168196-2017-02096
• Device Sequence Number: 19197802
• Product Code: HCG
• UDI-Device Identifier: 00814548013060
• UDI-Public: 00814548013060
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 11/02/2017

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: 02/05/2025
• Device Catalogue Number: RBY2C1857
• Device Lot Number: F74302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2017
• Initial Report FDA Received Date: 11/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 120