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

Catalog Number	RBY4C0835
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2019-00107.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery using a lantern delivery microcatheter (lantern) and ruby coils.During the procedure while attempting to advance the lantern through a non-penumbra diagnostic catheter, the physician experienced resistance after advancing the lantern approximately 20 centimeters into the diagnostic catheter and the lantern would not advance further.Therefore, the lantern was removed.The physician then advanced a non-penumbra microcatheter through the diagnostic catheter and placed two coils in the target vessel.While advancing a ruby coil out of its introducer sheath and into the microcatheter, the ruby coil made a friction noise and the physician tried to slowly retract the ruby coil.However, there was no one to one movement and when the physician retracted the ruby coil pusher assembly, the embolization coil did not move back in the introducer sheath.It was reported that only the tip of the ruby coil was inside the microcatheter and the physician just pulled the whole coil out of the microcatheter.The procedure was completed using four pod packing coils (podjs), two ruby coils and the same microcatheter.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 approximately 70.0 and 131.5 cm from the proximal end.The embolization coil was intact with its pusher assembly.The embolization coil was protruding out of the distal tip of introducer sheath and had offset coils winds.The introducer sheath had coagulated blood inside.Conclusions: evaluation of the ruby coil revealed that the embolization coil winds were offset.If the introducer sheath is not properly aligned within the hub of the microcatheter prior to advancement, resistance may be experienced causing embolization coil winds to become offset.These offset coil winds likely prevented the embolization coil from being retracted back into its introducer sheath during the procedure.Further evaluation of the returned ruby coil revealed that the pusher assembly was kinked in multiple locations.These kinks were likely incidental and may have occurred due to packaging of the ruby coil for return to penumbra.Evaluation of the non-penumbra guide catheter revealed no visible damage.During the functional test, resistance was encountered while attempting to advance a demonstration lantern through the non-penumbra guide catheter.Based on the dimensions of the guide catheter used in the procedure, the lantern would not be compatible through this non-penumbra device.This likely contributed to the reported resistance while attempting to advance the lantern into the non-penumbra guide during the procedure.The lantern identified in the complaint was not returned to penumbra for evaluation.Penumbra catheters and 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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8253550
• Report Number: 3005168196-2019-00108
• Device Sequence Number: 1582636
• Product Code: HCG
• UDI-Device Identifier: 00814548013206
• UDI-Public: 00814548013206
• 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): 12/18/2018
• 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: 08/16/2024
• Device Catalogue Number: RBY4C0835
• Device Lot Number: F71183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 01/16/2019
• Supplement Report FDA Received Date: 04/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 110
• Date Report Sent to FDA: 01/01/2005