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

Model Number	RBY2C0630-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
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers:1.3005168196-2020-00910 3005168196-2020-00910, 3005168196-2020-00912, 3005168196-2020-00913, 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.
Additional Manufacturer Narrative
Results: the embolization coil was stuck within the lantern.The stretch resistance wire (sr wire) was fractured and the proximal constraint sphere was not present at the proximal end of the embolization coil.Conclusions: evaluation of the first lantern revealed a distal ovalization.If the device is forcefully gripped or pinched during use, damage such as a distal ovalization may occur.This ovalization may have contributed to the reported resistance experienced during advancing the first ruby coil and caused the first ruby coil to become stuck within the lantern.Evaluation of the first ruby coil confirmed that the embolization coil was stuck within the first lantern.Further evaluation of the device revealed that the sr wire was fractured.If the device is forcefully advanced against resistance within the lantern, the embolization coil may become stuck and subsequently the embolization coil is retracted against the resistance, the sr wire may become fractured.The resistance was due to the ovalization in the first lantern.Evaluation of the second ruby coil revealed that the sr wire was fractured, and the embolization coil was unraveled.If the device is forcefully retracted against resistance, damage such as this may occur.The resistance was likely contributed by the ovalization on the second lantern which was used in the procedure.Evaluation of the second lantern revealed a distal ovalization.If the device is forcefully gripped or pinched during use, damage such as a distal ovalization may occur.This ovalization may have contributed to the reported resistance experienced during advancing the second ruby coil and caused the second ruby coil to become damaged.Penumbra coils and catheters 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.This report is associated with mfr report numbers: 1.3005168196-2020-00910, 2.3005168196-2020-00912, 3.3005168196-2020-00913, 4.3005168196-2020-00914, 5.3005168196-2020-00915.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10256294
• Report Number: 3005168196-2020-00911
• Device Sequence Number: 2964043
• Product Code: HCG
• UDI-Device Identifier: 00814548012940
• UDI-Public: 00814548012940
• 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,Followup
• 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: RBY2C0630-A
• Device Catalogue Number: RBY2C0630
• Device Lot Number: F91751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 09/23/2020
• 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