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

Catalog Number	RBY2C1460
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	06/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked in multiple locations.The embolization coil was intact with its pusher assembly and had offset coil winds along its length.Conclusions: evaluation of the returned ruby coil revealed offset coil winds on the embolization coil.If the device is forcefully manipulated against resistance, the coil may become compressed and offset coil winds may result.These offset coil winds may have contributed to additional resistance experienced during the procedure.Further evaluation revealed the ruby coil pusher assembly was kinked in multiple locations.These kinks were likely incidental to the reported failure and may have occurred while packaging the device for return to penumbra.The ruby coil introducer sheath and the lantern identified in the complaint were not returned to penumbra for evaluation.Due to the returned condition of the ruby coil, the root cause of the reported resistance could not be determined.Penumbra coils and catheters 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 was undergoing a coil embolization procedure in the splenic artery using ruby coils.During the procedure, while advancing a ruby coil through a lantern delivery microcatheter (lantern), the physician experienced resistance and the ruby coil would not advance; therefore, it was removed.The procedure was completed using another ruby coil and the same lantern.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: 7664087
• Report Number: 3005168196-2018-01335
• Device Sequence Number: 2515440
• Product Code: HCG
• UDI-Device Identifier: 00814548013046
• UDI-Public: 00814548013046
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 06/07/2018

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: Physician
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: RBY2C1460
• Device Lot Number: F42193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 07/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR