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

Model Number	RBY2C3260-A
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/04/2020
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 number: 3005168196-2020-00676.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat an aorta endoloak using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, a ruby coil was introduced into the lantern and was unable to advance more than 20-30 cm.Therefore, the ruby coil was removed.The next ruby coil was unable to advance more than 30-40 cm into the lantern.Therefore, this ruby coil was also removed.The procedure was completed using five additional 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Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.The embolization coil was intact with the pusher assembly.Offset coil winds were present in the middle of the embolization coil.Conclusions: evaluation of the returned ruby coil revealed offset coil winds in the middle of the embolization coil.If the device is advanced against resistance, damage such as offset coil winds may occur.During functional testing, the ruby coil was advanced through a demonstration lantern without an issue.The root cause of the resistance experienced during the procedure could not be determined.Further evaluation of the returned ruby coil revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.This damage was likely incidental to the reported complaint.Penumbra coils are inspected during in-process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 number: 1.3005168196-2020-00676 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: 10094179
• Report Number: 3005168196-2020-00675
• Device Sequence Number: 14304524
• Product Code: HCG
• UDI-Device Identifier: 00814548013107
• UDI-Public: 00814548013107
• 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): 05/04/2020
• 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: RBY2C3260-A
• Device Catalogue Number: RBY2C3260
• Device Lot Number: F92458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/04/2020
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 05/27/2020
• Supplement Report FDA Received Date: 08/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005