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

Model Number	RBY2C3260-A
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	04/27/2020
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: 1.3005168196-2020-01533.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat an occlusion of the pelvic varices using a px slim delivery microcatheter (px slim) and ruby coils.During the procedure, the distal tip of the px slim became damaged while in use in the patient.Subsequently, a ruby coil unintentionally detached inside the microcatheter.No additional information has been provided.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was updated based on additional information received by penumbra distributor: 1.Section b.Box 5.Describe event or problem please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was disposed of and is no longer available for return.Therefore, without the return of the device, the root cause of the problem cannot be determined.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: 1.3005168196-2020-01533.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat an occlusion of the pelvic varices using a px slim delivery microcatheter (px slim) and ruby coils.During the procedure, the distal tip of the px slim became damaged while in use in the patient.Subsequently, a ruby coil unintentionally detached inside the microcatheter and was removed from the procedure.The procedure was completed using additional coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the device in complaint was not expected to be returned; however, on 02-feb-2021 the device was received.Based on this information, corrections were made to: 1.Section d.Box 10: device available for evaluation? (do not send to fda).2.Section h.Box 3: device returned to manufacturer? 3.Section h.Box 3: device evaluated by manufacturer? 4.Section h.Box 6: method code 1, method code 2, and method code 3.5.Section h.Box 6: results code 1.6.Section h.Box 6.Conclusions code 1.Additional information was added to: 1.Section d.Box 10: returned to manufacturer on (mm/dd/yyyy).Evaluation of the returned ruby coil confirmed that the embolization coil was detached from its pusher assembly.If the ruby coil is forcefully retracted against resistance, the pusher assembly may elongate beyond the length of the pull wire inside the ddt, causing the embolization coil to detach from its pusher assembly.The damage to the distal tip of the pxslim mentioned in the complaint may have contributed to resistance during the procedure.Further evaluation of the returned ruby coil revealed offset coil winds along the length of the embolization coil.This damage was incidental to the reported complaint and may have occurred during packaging of the device for returned.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: 1.3005168196-2020-01533 h3 other text : placeholder.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10557403
• Report Number: 3005168196-2020-01534
• Device Sequence Number: 2842857
• Product Code: HCG
• UDI-Device Identifier: 00814548013107
• UDI-Public: 00814548013107
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2020
• 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: 10/01/2026
• Device Model Number: RBY2C3260-A
• Device Catalogue Number: RBY2C3260
• Device Lot Number: F86204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/20/2020
• Supplement Date Received by Manufacturer: 09/21/2020; 03/19/2021
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 01/27/2021; 04/16/2021
• 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