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

Model Number	RBY4C0630-A
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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: 3005168196-2020-00910, 3005168196-2020-00911, 3005168196-2020-00912, 3005168196-2020-00914, 3005168196-2020-00915.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a type ib endoleak in the in lumbar artery using lantern delivery microcatheters (lanterns), ruby coils, a non-penumbra sheath and a non-penumbra selective catheter.It was noted that the patient¿s vessel anatomy was elongated and tortuous.During the procedure, the physician advanced lantern to the target vessel using the sheath and selective catheter.While advancing a ruby coil through the lantern, the ruby coil became stuck at the marker band on the distal end of the lantern.Therefore, the ruby coil and lantern were removed together from the patient.The physician then advanced a new lantern into the target vessel.While advancing a new ruby coil through the lantern, the ruby coil became stuck at the marker band on the distal end of the lantern; therefore, the ruby coil was removed.It was reported that after removing the ruby coil from the lantern, it was noticed that the ruby coil was damaged and was unable to be retracted back into its introducer sheath.Next, the physician advanced another ruby coil through the lantern, but the ruby coil also became stuck like the first two ruby coils.Therefore, the ruby coil was removed.After the three unsuccessful attempts to embolize the lumbar artery, the physician decided to just fill the endoleak sac with coils.The physician then repositioned the lantern into the endoleak sac and attempted to advance a new ruby coil; however, the ruby coil became stuck at the distal tip of the lantern.Therefore, the ruby coil and lantern were removed together from the patient.It was also reported that after removing the ruby coil from the lantern, it was noticed that the ruby coil was damaged and was unable to be retracted back into its introducer sheath.The procedure was completed using additional ruby coils, pod packing coils (pod pcs) and another microcatheter.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10256305
• Report Number: 3005168196-2020-00913
• Device Sequence Number: 2964045
• Product Code: HCG
• UDI-Device Identifier: 00814548013190
• UDI-Public: 00814548013190
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/17/2020
• 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: RBY4C0630-A
• Device Catalogue Number: RBY4C0630
• Device Lot Number: F87832
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 07/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Date Report Sent to FDA: 01/01/2005