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

Model Number	RBYLP0304
Medical Device Problem Code	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	08/31/2020
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 number: 3005168196-2020-01572.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the middle hepatic artery using ruby coil lps, guide catheter and non-penumbra microcatheter.During the procedure, while attempting to advance a ruby coil lp, the hospital technician experienced resistance and the ruby coil lp would not advance from the starting position within the introducer sheath.Therefore, the ruby coil lp was removed and the microcatheter was flushed with saline.It was reported that the ruby coil lp was also placed into a bowl of saline.While making another attempt to advance the same ruby coil lp, the physician experienced the same resistance; subsequently, the pusher assembly of the ruby coil lp became bent and, therefore, it was removed.The physician then placed a new ruby coil lp in the target vessel.While attempting to advance another ruby coil lp, the physician initially experienced resistance while advancing the coil from the starting position within the introducer sheath.Subsequently, the ruby coil lp was able to advance past the friction lock within the introducer sheath and was successfully placed in the vessel.The procedure was completed at this point.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pusher assembly was kinked at approximately 109.0 cm and 140.0 cm from the proximal end.The pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.The embolization coil was undamaged and intact with the pusher assembly.Conclusions: evaluation of the returned ruby coil lp confirmed a pusher assembly kink and revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If this occurs, resistance will likely be experienced while advancing the device.Forceful advancement the device against this resistance may result in a pusher assembly kink.During functional testing, the ruby coil lp was unable to advance from its returned position due to the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.After properly re-sheathing the device into its introducer sheath, the ruby coil lp was able to advance through its introducer sheath and a demonstration microcatheter with resistance due to the kink on the pusher assembly.Further evaluation of the device revealed an additional kink on the pusher assembly.This kink was likely incidental to the complaint.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: 3005168196-2020-01572.

• Brand Name: RUBY COIL LP
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10586956
• Report Number: 3005168196-2020-01571
• Device Sequence Number: 1245924
• Product Code: HCG
• UDI-Device Identifier: 00815948021778
• UDI-Public: 00815948021778
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 08/31/2020
• 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: 06/17/2025
• Device Model Number: RBYLP0304
• Device Catalogue Number: RBYLP0304
• Device Lot Number: F98412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Date Report Sent to FDA: 01/01/2005