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

Catalog Number	RBY2C1240
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	10/24/2017
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 splenic artery using ruby coils.During the procedure, the physician deployed and detached an initial ruby coil into the target vessel using a lantern delivery microcatheter (lantern).While attempting to advance a new ruby coil through the lantern, the physician experienced resistance and was unable to advance the coil through the lantern.Subsequently, the physician removed the ruby coil and changed the rotating hemostasis valve (rhv) to a new one.Next, the physician made another attempt to advance the ruby coil through the lantern but was unsuccessful.Therefore, the ruby coil was removed and the procedure was completed using four new ruby coils, the same lantern and the second rhv.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Result: the pet lock was intact on the proximal end of the pusher assembly.The embolization coil was intact with its pusher assembly.Conclusion: evaluation of the returned ruby coil revealed that the device was undamaged and functional.The ruby coil was able to be advanced through a demonstration microcatheter and out of the distal tip without an issue.The root cause of the reported resistance could not be determined.Evaluation of the returned lantern revealed that the hub had a clear substance inside.This clear substance may have been contrast used in the procedure.This substance prevented the returned ruby coil from being advanced through the device during functional testing.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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7049053
• Report Number: 3005168196-2017-02008
• Device Sequence Number: 1119588
• Product Code: HCG
• UDI-Device Identifier: 00814548013015
• UDI-Public: 00814548013015
• Combination Product (Y/N): N
• 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): 10/24/2017

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: 05/23/2024
• Device Catalogue Number: RBY2C1240
• Device Lot Number: F69473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Initial Date Received by Manufacturer: 10/24/2017
• Supplement Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 06/22/2018
• 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