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

Model Number	RBY4C1035-B
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2021
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a renal arteriovenous fistula (avf) using ruby coils, a non-penumbra microcatheter and non-penumbra catheters.It should be noted that the patient's anatomy was tortuous and calcified.During the procedure, the microcatheter was placed in the avf shunt and subsequently, resistance was encountered while advancing the distal part of the first ruby coil in the distal tip of the microcatheter.Therefore, the ruby coil was removed.The procedure was completed using a pod coil, a ruby coil, and a pod packing coil (pod pc) with the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ruby coil revealed offset coil winds.If the device is forcefully advanced against resistance, damage such as this may occur.The ruby coil was returned without its introducer sheath; therefore, the ruby coil was re-sheathed with a demonstration introducer sheath; subsequently, the ruby coil was unable to be advanced or retracted any further within the introducer sheath.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.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: 12105007
• Report Number: 3005168196-2021-01461
• Device Sequence Number: 3705102
• Product Code: HCG
• UDI-Device Identifier: 00814548018669
• UDI-Public: 00814548018669
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2021
• 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: RBY4C1035-B
• Device Catalogue Number: RBY4C1035
• Device Lot Number: F87472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/06/2021
• Supplement Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 08/02/2021
• 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