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

Model Number	RBY4C0835-B
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/29/2020
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) ruby coils and lantern delivery microcatheter (lantern).During the procedure, while advancing a ruby coil through lantern, the pusher assembly of the ruby coil was inadvertently kinked.Therefore, the ruby coil was removed.The procedure was completed using additional ruby coils, a pod packing coil and the same lantern.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of the pusher assembly.The pusher assembly was fractured approximately 36.0 cm from the proximal end, and the pull wire was retracted out of the distal fractured segment.Bends were present along the length of the pusher assembly.The embolization coil was detached from the pusher assembly and was not returned for evaluation.Conclusions: evaluation of the returned ruby coil revealed a fractured pusher assembly.If the device is forcefully advanced against resistance or is otherwise mishandled at extreme angels during use, damaged such as kink and subsequent fracture may occur.Further evaluation of the device revealed that the pull wire was retracted out of the distal fractured segment and the embolization coil was detached from the pusher assembly and was not returned for evaluation.These damages were likely incidental to the complaint.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.H3 other text : placeholder.
Additional Manufacturer Narrative
Correction: please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #02 mfr report:3005168196-2020-01229.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10428794
• Report Number: 3005168196-2020-01229
• Device Sequence Number: 2344625
• Product Code: HCG
• UDI-Device Identifier: 00814548018386
• UDI-Public: 00814548018386
• Combination Product (Y/N): Y
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• 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,Followup
• Report Date (Section B): 07/29/2020
• 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 Model Number: RBY4C0835-B
• Device Catalogue Number: RBY4C0835
• Device Lot Number: F91855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/29/2020
• Supplement Date Received by Manufacturer: 08/26/2020; 01/14/2005
• Initial Report FDA Received Date: 08/19/2020
• Supplement Report FDA Received Date: 09/21/2020; 09/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Date Report Sent to FDA: 01/01/2005