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

Catalog Number	RBY4C0204
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	01/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The embolization coil was intact with its pusher assembly and the coil winds were offset.The pusher assembly was fractured approximately 5.0 cm from the proximal end.Conclusions: evaluation of the returned device revealed that the ruby coil's embolization coil winds were offset and the pusher assembly was fractured.Offset coil winds typically occur due to improper handling during use.If the device is forcefully manipulated against resistance while within a microcatheter, damage such as this may occur.Further evaluation of the returned device revealed that the ruby coil's pusher assembly was fractured.This fracture was likely incidental and may have occurred while packaging the device for return to penumbra.The root cause of the reported resistance could not be determined.The ruby coil was attempted to be advanced through a demonstration microcatheter.While loading a demonstration introducer sheath on the returned ruby coils pusher assembly, the fractured portion of the pusher could not be advanced through the sheath.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation.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.
Event or Problem Description
The patient undergoing a coil embolization procedure in the celiac artery using ruby coils.During the procedure, the physician felt resistance and was unable to advance a ruby coil within a non-penumbra microcatheter, and therefore the ruby coil was removed.The procedure was then completed using a new ruby coil and the same microcatheter.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: 7284168
• Report Number: 3005168196-2018-00371
• Device Sequence Number: 1028888
• Product Code: HCG
• UDI-Device Identifier: 00814548013138
• UDI-Public: 00814548013138
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Type of Report: Initial
• Report Date (Section B): 01/22/2018

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: 07/24/2025
• Device Catalogue Number: RBY4C0204
• Device Lot Number: F78356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 02/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 91