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

Catalog Number	RBY4C2060
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2019
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right transfemoral artery using a ruby coil and a pod packing coil (podj).During the procedure, the physician attempted to advance a ruby coil through a lantern delivery microcatheter (lantern); however, after advancing approximately 20 cm into the lantern, the ruby coil remained stuck before reaching the distal end of the lantern.Therefore, the ruby coil was removed and a new ruby coil was successfully implanted.The physician then attempted to place a podj; however, resistance was experienced and the podj unintentionally detached within the lantern while being retracted.The lantern containing the detached podj was removed from the patient and the procedure was completed using a new podj and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the ruby coil embolization coil was detached from its pusher assembly and stuck inside its introducer sheath.The embolization coil had offset coil winds and was intact with the proximal constraint sphere.Conclusions: evaluation of the returned ruby coil revealed that the embolization coil had offset coil winds.If the device was forcefully advanced against the resistance experienced during the procedure, damage such as offset coil winds may occur.These offset coils may contribute to resistance during subsequent attempts to manipulate the coil.The root cause of the initial resistance could not be determined.Further evaluation revealed that the embolization coil was detached within its introducer sheath and the pusher assembly was not returned for evaluation.This detachment was likely incidental to the reported complaint.Evaluation of the returned podj revealed that the sr wire was fractured.If the podj is forcefully retracted against resistance, damage such as a sr wire fracture may occur.The root cause of resistance could not be determined.The pusher assembly to the podj was not returned to penumbra for evaluation.Evaluation of the returned lantern revealed a functional device.The returned podj was flushed out of the lantern then a demonstration coil was advanced through the returned lantern and out of the distal tip without an issue.The ruby coil and podj pusher assemblies were not returned to penumbra for evaluation.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: 1.3005168196-2019-01459 h3 other text : placeholder.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8832320
• Report Number: 3005168196-2019-01458
• Device Sequence Number: 226449
• Product Code: HCG
• UDI-Device Identifier: 00814548013251
• UDI-Public: 00814548013251
• 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): 06/27/2019
• 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: 04/15/2026
• Device Catalogue Number: RBY4C2060
• Device Lot Number: F82881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 07/26/2019
• Supplement Report FDA Received Date: 08/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Date Report Sent to FDA: 01/01/2005