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

Catalog Number	RBY2C0725
Medical Device Problem Codes	Failure to Fold (1255); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2019
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 splenic artery using ruby coils.During the procedure, the physician advanced the ruby coil to the target vessel, and it was not shaping; subsequently, the physician decided to re-sheath the ruby coil and try another size.While re-sheathing the ruby coil, the ruby coil became stuck and would not re-sheath; therefore, the ruby coil was removed unsheathed.It was reported that the pusher assembly of the ruby coil was stuck inside its sheath.The procedure was completed using another ruby coil.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 its pusher assembly.The pusher assembly was kinked approximately 5.0, 11.0, and 54.0 cm from its proximal end.The embolization coil was intact with its pusher assembly and had coagulated blood along its length.The embolization also had offset coil winds on the proximal end.Conclusions: evaluation of the returned ruby coil revealed that the embolization coil shape was present.After decontaminating the ruby coil to loosen the coagulated blood.The ruby coil was re-sheathed and advanced out of its introducer sheath and its intended shape was present.The root cause of the coil not shaping during the procedure could not be determined.The coagulated blood also prevented the ruby coil from being re-sheathed prior to decontamination.Further evaluation of the returned ruby coil revealed that the pusher assembly was kinked.These kinks were likely incidental to the reported complaint.During the functional test, the ruby coil was advanced through a demonstration lantern with resistance while advancing the proximal kink on the pusher assembly through the introducer sheath.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: 9377075
• Report Number: 3005168196-2019-02207
• Device Sequence Number: 18947288
• Product Code: HCG
• UDI-Device Identifier: 00814548018836
• UDI-Public: 00814548018836
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• 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): 10/31/2019
• 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: 09/26/2026
• Device Catalogue Number: RBY2C0725
• Device Lot Number: F86119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 12/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Date Report Sent to FDA: 01/01/2005