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

Model Number	RBY4C0860-B
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right iliac vein using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician successfully implanted a ruby coil in the target vessel using the lantern.The physician then advanced another ruby coil to the target vessel using the lantern and removed the introducer sheath.Subsequently, the ruby coil was noticed to be stretched and exiting the lantern.Therefore, the ruby coil was retracted and removed.The procedure was completed using another ruby coil and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil revealed offset coil winds on the proximal end of the embolization coil.This damage is likely the reported stretched coil.If the ruby coil is retracted against resistance, damage such as offset coil winds may occur.During functional testing, the ruby coil was sheathed with a demonstration introducer sheath and then advanced out without an issue.Subsequently, the ruby coil was advanced and retracted through a demonstration lantern with minor resistance due to the offset coil winds.The root cause of resistance during the procedure could not be determined.The root cause of resistance during the procedure could not be determined.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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 12760087
• Report Number: 3005168196-2021-02500
• Device Sequence Number: 3439594
• Product Code: HCG
• UDI-Device Identifier: 00814548018393
• UDI-Public: 00814548018393
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/05/2021
• 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: RBY4C0860-B
• Device Catalogue Number: RBY4C0860
• Device Lot Number: F100316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• Is the Reporter a Health Professional?: Yes
• 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: 10/11/2021
• Initial Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 2 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005