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

Model Number RBYLP0430

Device Problems Failure to Advance (2524); Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/19/2021

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2021-00766.

Event Description

The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using ruby coil lps, a non-penumbra microcatheter, a non-penumbra catheter, a non-penumbra sheath, and a guidewire.During the procedure, after placing the sheath into the right common femoral artery, a catheter was advanced into the celiac artery and the microcatheter was advanced over the guidewire.After removing the guidewire, a 3 cc syringe as used to flush the microcatheter and subsequently, a ruby coil lp was advanced into the microcatheter.While advancing the ruby coil lp, the physician encountered resistance and the coil became stuck approximately five centimeters proximal to the tip of the microcatheter.The physician retracted the ruby coil lp and was unable to re-advance it; therefore, the physician decided to remove the coil from the procedure.Upon removal, the physician inadvertently bent the ruby coil lp pusher wire.After flushing the microcatheter using the same 3 cc syringe, another ruby coil lp was advanced into the same microcatheter and the same issue occurred.Therefore, the ruby coil lp was removed.The ruby coil lp was advanced into saline solution for cleaning and subsequently re-sheathed.A new microcatheter of the same type was then used.While attempting to re-advance the same ruby coil lp through the new microcatheter, the coil would not move in its introducer sheath.Therefore, the ruby coil lp was no longer used in the procedure.The procedure was completed using two new ruby coil lps and the same microcatheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the first returned ruby coil lp revealed offset coil winds on the proximal end of the embolization coil.If the device is forcefully manipulated against resistance, damage such as this may occur.Further evaluation revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock, the introducer sheath was ovalized on its proximal end, and the pusher assembly had kinks.This damage was likely incidental to the reported complaint and may have occurred after removal from the procedure.During functional testing, the ruby coil was only able to advance slightly from its returned position within the introducer sheath before additional resistance was experienced due to the ovalization in the introducer sheath and the offset coil winds, and the ruby coil lp could not advance any further.The root cause of the initial resistance during the procedure could not be determined.Evaluation of the second returned ruby coil lp revealed offset coil winds on the proximal end of the embolization coil.If the device is forcefully manipulated against resistance, damage such as this may occur.During functional testing, the ruby coil lp was only able to advance slightly from its returned position within the introducer sheath before strong resistance was experienced due to the offset coil winds, and the ruby coil lp could not advance any further.The root cause of the initial resistance during the procedure could not be determined.Further evaluation of the device revealed pusher assembly kinks.This damage was likely incidental to the 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: 3005168196-2021-00766.

• Brand Name: RUBY COIL LP
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11675478
• MDR Text Key: 245747661
• Report Number: 3005168196-2021-00767
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00815948021822
• UDI-Public: 00815948021822
• Combination Product (y/n): Y
• PMA/PMN Number: K192955
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RBYLP0430
• Device Catalogue Number: RBYLP0430
• Device Lot Number: F103321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR