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

Catalog Number	RBY2C3260
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	04/10/2019
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: 3005168196-2019-00918.
Event or Problem Description
The patient was undergoing a coil embolization procedure in common iliac artery using a ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the distal tip of the lantern was found to be kinked upon removal from the packaging and, therefore, it was not used in the procedure.Next, the physician experienced resistance and the ruby coil would not advance within its introducer sheath and, therefore, it was removed.The procedure was completed using a new ruby coil with a new 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 at approximately 82.0 cm from the proximal end.The embolization coil was intact with the pusher assembly and had offset coil winds.The introducer sheath was ovalized at approximately 112.0 cm from proximal end sheath.During functional testing, the ruby coil was attempted to be advanced through its introducer sheath and resistance was encountered at the introducer sheath ovalization.The embolization coil was unable to advance further.Conclusions: evaluation of the returned ruby coil revealed an ovalization on its introducer sheath.If the introducer sheath is forcefully handled or pinched, damage such as an ovalization may occur and resistance may be experienced when attempting to advance the device.Further investigation revealed that the pusher assembly had a kink and the embolization coil had offset coil winds.If the ruby coil is forcefully advanced against resistance, damage such as this may occur.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 number: 1.3005168196-2019-00918.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8600145
• Report Number: 3005168196-2019-00917
• Device Sequence Number: 2281158
• Product Code: HCG
• UDI-Device Identifier: 00814548013107
• UDI-Public: 00814548013107
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2019
• 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: 03/14/2025
• Device Catalogue Number: RBY2C3260
• Device Lot Number: C10871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 07/25/2019
• 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