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

Model Number	RBY2C0415-B
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/21/2020
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.This report is associated with mfr report number: 3005168196-2020-01201.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, while advancing a ruby coil out of its introducer sheath and into the lantern, the pusher assembly of the ruby coil kinked.Therefore, the ruby coil was removed.It was reported that the hospital technician advanced too big of a portion of the pusher assembly through the introducer sheath.An attempt was made to advance another ruby coil; however, the same issue occurred.Therefore, the ruby coil was removed.The procedure was completed using three ruby coils and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was broken on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 29.0 cm from its proximal end.The embolization coil was detached from its pusher assembly.Conclusions: evaluation of the first returned ruby coil revealed that the pusher assembly was kinked and fractured.If the device is forcefully advanced against resistance, damage such as a kink may occur.Further manipulation of a kinked pusher assembly may result in a fracture.Further evaluation of the returned ruby coil revealed that the embolization coil was detached.This damage likely occurred due to the separation of the two fractured segments, which resulted in the pull wire being retracted out of distal detachment tip (ddt) and allowing the coil to be released from its pusher assembly.Evaluation of the second returned ruby coil confirmed that the pusher assembly was kinked.If the device is forcefully advanced against resistance, damage such as a kinked may occur.Further evaluation of the returned ruby coil revealed a broken pet lock on the proximal end of the pusher assembly, and the embolization coil was detached.If the device is mishandled during use, damage such as a broken pet lock may occur.If the pet lock is broken, the pull wire will retract out of the ddt and the embolization coil will detach from its pusher assembly.Both embolization coils were not returned for evaluation.Penumbra coils 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.H3 other text : placeholder.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10408500
• Report Number: 3005168196-2020-01202
• Device Sequence Number: 3120593
• Product Code: HCG
• UDI-Device Identifier: 00814548018584
• UDI-Public: 00814548018584
• 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
• Report Date (Section B): 07/22/2020
• 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 Expiration Date: 06/06/2026
• Device Model Number: RBY2C0415-B
• Device Catalogue Number: RBY2C0415
• Device Lot Number: F83907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/22/2020
• Supplement Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005