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

Model Number	RBYLP0315
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2020
Type of Reportable Event	Malfunction
Additional 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 numbers: 3005168196-2020-01717, 3005168196-2020-01718.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the superior mesenteric artery (sma) using ruby coil lps.During the procedure, while attempting to advance a ruby coil lp in the introducer sheath, the ruby coil lp would not move and was stuck.Subsequently, the ruby coil lp was removed.The physician attempted to advance the ruby coil lp again on the back table, but the ruby coil lp was stuck.The physician attempted the same process with two other ruby coil lps, and the same issue occurred.Therefore, the three ruby coil lps were not used for the remainder for the procedure.The procedure was completed using non-penumbra coils.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 its pusher assembly.The pusher assembly was kinked approximately 137.0 cm from its proximal end.The pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.The embolization coil was intact with its pusher assembly and undamaged.Conclusions: evaluation of the first returned ruby coil lp revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If this occurs, resistance will likely be experienced while attempting to advance the device through its introducer sheath.Subsequently, forcefully advancing the device against the resistance may have contributed to the pusher assembly kink, which was observed near the pusher assembly mid-joint.During the functional test, resistance was encountered while attempting to advance the pusher assembly through its introducer sheath from its returned position, and the pusher assembly could not be advanced any further.The ruby coil lp was retracted from its introducer sheath and re-sheathed properly.Resistance was then encountered while attempting to advance the kinked pusher assembly through the hub of the demonstration microcatheter, and the ruby coil lp could not be advanced any further.Evaluation of the second returned ruby coil lp revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If this occurs, resistance will likely be experienced while attempting to advance the device through its introducer sheath.During the functional test, resistance was encountered while attempting to advance the pusher assembly through its introducer sheath from its returned position, and the pusher assembly could not be advanced any further.The ruby coil lp was retracted from its introducer sheath and re-sheathed properly.The ruby coil lp was then advanced through a demonstration microcatheter without an issue.Evaluation of the third returned ruby coil lp revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If this occurs, resistance will likely be experienced while attempting to advance the device through its introducer sheath.Subsequently, forcefully advancing the device against the resistance may have contributed to the pusher assembly kink, which was observed near the pusher assembly mid-joint.During the functional test, resistance was encountered while attempting to advance the pusher assembly through its introducer sheath from its returned position, and the pusher assembly could not be advanced any further.The ruby coil lp was retracted from its introducer sheath and re-sheathed properly.The ruby coil lp was then advanced through a demonstration microcatheter without an issue.Penumbra coils are visually 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: 1.3005168196-2020-01717 2.3005168196-2020-01718 h3 other text : placeholder.

• Brand Name: RUBY COIL LP
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10662397
• Report Number: 3005168196-2020-01716
• Device Sequence Number: 4283830
• Product Code: HCG
• UDI-Device Identifier: 00815948021792
• UDI-Public: 00815948021792
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K192955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2020
• 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 Expiration Date: 07/05/2025
• Device Model Number: RBYLP0315
• Device Catalogue Number: RBYLP0315
• Device Lot Number: F98710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/18/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 10/12/2020
• Supplement Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Date Report Sent to FDA: 01/01/2005