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

Catalog Number	RBY2C1660
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2019
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the inferior mesenteric artery (ima) using ruby coils and an indigo system aspiration catheter 6 (cat6).It was reported that the patient¿s anatomy was tortuous.During the procedure, the physician successfully placed four ruby coils in the target vessel using a lantern delivery microcatheter (lantern).While attempting to advance the next ruby coil through the lantern, the ruby coil became stuck in the lantern.The physician then attempted to reposition the lantern to remove the ruby coil, but it was again stuck; therefore, the ruby coil and lantern were removed as one unit.While flushing the lantern, a bunch of clot came out.It was reported that this may have been the contributing cause to the ruby coil becoming stuck in the lantern.The physician resumed the procedure using two other ruby coils and the same lantern.Upon performing the final angiogram, it was noticed that the ima was full of clot.Subsequently, a cat6 was opened to aspirate the clot.However, the cat6 was inadvertently dropped outside of the sterile field.The cat6 was contaminated prior to use, and therefore, it was not used in the procedure.The procedure was completed using another cat6.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 92.0 cm, 97.0 cm and 103.0 cm from the proximal end.The embolization coil was intact with the pusher assembly and had offset coil winds along its length.The ruby coil was retracted through its introducer sheath.Coagulated blood was present on the embolization coil and through the introducer sheath.Conclusions: evaluation of the returned ruby coil revealed that the embolization coil had offset coil winds.The complaint reported that the ruby coil was stuck inside the lantern during advancement due to the clot.If the device is forcefully manipulated against this resistance, damage such as offset coil winds may occur.Further investigation revealed that the pusher assembly was kinked, the ruby coil was retracted through its introducer sheath, the embolization coil was compressed, and coagulated blood was inside the introducer sheath.These damages were likely incidental to the complaint.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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9188363
• Report Number: 3005168196-2019-01926
• Device Sequence Number: 17006231
• Product Code: HCG
• UDI-Device Identifier: 00814548013053
• UDI-Public: 00814548013053
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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): 09/17/2019
• 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: 10/19/2024
• Device Catalogue Number: RBY2C1660
• Device Lot Number: F72422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 11/21/2019
• 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