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

Catalog Number	RBY2C0825
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2019-00236; 3005168196-2019-00238.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a bleed in the splenic artery using ruby coils.During the procedure, while attempting to advance a ruby coil through a non-penumbra catheter, the ruby coil was coiling inside the catheter and would not advance; therefore, it was removed.It was reported that the same issue occurred with two other ruby coils; therefore, the ruby coils and the catheter were removed.The procedure was completed using a lantern delivery microcatheter (lantern) and four additional ruby coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked at approximately 29.0 cm from the proximal end.The embolization coil was detached and not returned for evaluation.Coagulated blood was presented within the introducer sheath.Conclusions: evaluation of the returned ruby coils revealed three damaged devices.The reported complaint indicated that a 0.035 catheter was used to deliver the ruby coils in the procedure.The 0.035 catheter has a larger inner diameter which will allow the ruby coils to take shape within the catheter lumen.Advancing the ruby coils through the 0.035 catheter may result in resistance and the coils can become stuck inside the catheter.Forcefully advancing and retracting the coil against resistance may result in a damaged device.Further investigation revealed bends and kinks on the pusher assemblies on the returned devices.Those damages were likely incidental to the reported complaint and could have occurred during return to penumbra.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.This report is associated with mfr report numbers: 1.3005168196-2019-00236.2.3005168196-2019-00238.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8331134
• Report Number: 3005168196-2019-00237
• Device Sequence Number: 11088828
• Product Code: HCG
• UDI-Device Identifier: 00814548012971
• UDI-Public: 00814548012971
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2019
• 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: 11/26/2025
• Device Catalogue Number: RBY2C0825
• Device Lot Number: F80755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 02/12/2019
• Supplement Report FDA Received Date: 05/03/2019
• 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
• Date Report Sent to FDA: 01/01/2005