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

Catalog Number	RBY4C0835
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2019
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.This report is associated with mfr report number: 3005168196-2019-01845; 3005168196-2019-01846.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils.During the procedure, while attempting to advance the first two ruby coils through a lantern delivery microcatheter (lantern), the physician experienced resistance, and the ruby coils became stuck in the middle of the lantern; therefore, they were removed.The physician then successfully placed two other ruby coils in the target vessel.While advancing the next ruby coil through the lantern, the physician experienced resistance, and the ruby coil became stuck in the middle of the lantern; 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.
Additional Manufacturer Narrative
Results: the proximal constraint sphere was not present on the proximal end of the embolization coil.The stretch resistant (sr) wire was fractured and offset coil winds were present throughout the embolization coil.Conclusions: evaluation of the first returned ruby coil revealed offset coil winds on the embolization coil.If the device is forcefully advanced against resistance, damage such as this may occur.During functional testing, the ruby coil was unable to be advanced or retracted within its introducer sheath due to the offset coil winds.Further evaluation revealed pusher assembly kinks.These kinks were likely a result of mishandling during advancement against resistance.Evaluation of the second returned ruby coil revealed offset coil winds on the embolization coil.If the device is forcefully advanced against resistance, damage such as this may occur.During functional testing, the ruby coil was unable to be advanced or retracted within its introducer sheath due to the offset coil winds.Evaluation of the third ruby coil revealed a fractured sr wire and offset coil winds.Based on the reported complaint, these damages are likely incidental and may have occurred after the device was removed from use.If the sr wire fractures, the embolization coil will detach from the pusher assembly and damage such as offset coil wires may occur.The pusher assembly was not returned for evaluation, and the embolization was too damaged to assess cause of the reported complaint.Evaluation of the returned lantern revealed an undamaged, functional device.During functional testing, a demonstration ruby coil was advanced through the lantern without an issue.The root cause of the resistance experienced during advancement of the three complaint ruby coils could not be determined.There were no allegations against the non-penumbra catheter.The device was undamaged.Penumbra coils are 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.Conclusions code: 4316 the investigation findings do not lead to a clear conclusion about the root cause of resistance and advancement issue this report is associated with mfr report number: 3005168196-2019-01845, and 3005168196-2019-01846.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9141877
• Report Number: 3005168196-2019-01847
• Device Sequence Number: 3046862
• Product Code: HCG
• UDI-Device Identifier: 00814548013206
• UDI-Public: 00814548013206
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• 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): 09/04/2019
• 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: 05/15/2025
• Device Catalogue Number: RBY4C0835
• Device Lot Number: C10293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 12/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005