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

Model Number	RBYLP0530
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2020
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: 3005168196-2020-00370.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coil lp, pod packing coil lp, and non-penumbra microcatheter.During the procedure, a ruby coil lp was stuck and would not advance at all within its introducer sheath and, therefore, the ruby coil lp was removed.It was also reported that the physician attempted to advance the same ruby coil lp on the back table, but the coil would not advance within the introducer sheath.The physician then attempted to advance a pod packing coil lp into the microcatheter; however, the same issue occurred, and the coil would not advance at all within its introducer sheath.Therefore, the pod packing coil lp was removed.The procedure was completed using a new ruby coil lp and the same microcatheter.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pusher assembly was kinked approximately 18.0, 21.0, and 139.0 cm from its proximal end.The pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.The embolization coil was undamaged and intact with its distal detachment tip (ddt).Conclusions: evaluation of the returned ruby lp revealed that the pusher assembly mid-joint was retracted proximal to the introducer sheath friction lock.If this damage occurs, resistance may be encountered during advancement, and the ruby lp may not advance through its introducer sheath.During the functional test, the ruby lp was unable to be advanced from its returned position.The ruby lp was unsheathed distally and re-sheathed correctly.Then the ruby lp was able to be advanced through its introducer sheath with resistance due to the kink caused by the penumbra investigator.Further evaluation revealed pusher assembly kinks.These kinks were likely incidental to the reported complaint.No other devices associated with the complaint were returned for evaluation.Penumbra catheters 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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9844656
• Report Number: 3005168196-2020-00369
• Device Sequence Number: 19023884
• Product Code: HCG
• UDI-Device Identifier: 00815948021846
• UDI-Public: 00815948021846
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 02/20/2020
• 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: 12/11/2024
• Device Model Number: RBYLP0530
• Device Catalogue Number: RBYLP0530
• Device Lot Number: F94895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/20/2020
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Date Report Sent to FDA: 01/01/2005