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

Model Number	RBYLP0406
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2020
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: 3005168196-2020-01739.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the pelvic using ruby coil lps.During the procedure, a ruby coil lp would not come out of the introducer sheath.It was reported that while attempting to remove the ruby coil lp under force, the ruby coil lp kinked.Subsequently, the ruby coil lp was removed.The physician continued with the procedure using another ruby coil lp.The ruby coil lp detached in the introducer sheath.Therefore, the ruby coil lp was also removed.The procedure was completed using ruby 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 the pusher assembly.The pusher assembly was kinked approximately 45.0 cm, 86.0 cm and 136.0 cm from the proximal end.The pusher assembly was fractured approximately 138.0 cm from the proximal end.The pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.The pull wire was retracted form the pusher assembly distal detachment tip (ddt).The embolization coil was detached from the pusher assembly and undamaged.Conclusions: evaluation of the first returned ruby coil lp confirmed pusher assembly kink.If the device is forcefully mishandled during use, damage such as pusher assembly kink may occur.During functional testing, the embolization coil was able to advance through its introducer sheath without issue.Then the ruby coil lp was able to advance through a demonstration microcatheter with resistance due to the pusher assembly kink.The reported ruby coil lp unable to advance out of its introducer sheath could not be confirmed.Further evaluation of the device revealed additional kinks on the pusher assembly.This damage was likely incidental to the complaint and may have occurred during packaging for the device return.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 advancing the device and the device may not be advanced out of its introducer sheath.Forcefully advancing the device against this resistance may have contributed to the kink and fracture which were observed near the pusher assembly mid-joint.If the pusher assembly was fractured and the pull wire was retracted from the ddt, the embolization coil may detach from the pusher assembly.Further evaluation of the device revealed kinks throughout the pusher assembly.This damage was likely incidental to the complaint and may have occurred during packaging for the device return.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 number: 1.3005168196-2020-01739.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: 10691136
• Report Number: 3005168196-2020-01740
• Device Sequence Number: 14436600
• Product Code: HCG
• UDI-Device Identifier: 00815948021808
• UDI-Public: 00815948021808
• Combination Product (Y/N): Y
• Initial Reporter State: ME
• 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): 09/24/2020
• 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: 06/25/2025
• Device Model Number: RBYLP0406
• Device Catalogue Number: RBYLP0406
• Device Lot Number: F98562
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 12/10/2020
• 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