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

Model Number	RBY2C1240-A
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/14/2019
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils and a lantern delivery microcatheter (lantern).During the procedure, the physician implanted the initial ruby coils into the target vessel.While attempting to advance another ruby coil through the lantern, the physician experienced resistance; therefore, the ruby coil was removed.The procedure was completed using additional ruby coils and the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the ruby coil had bends along the length of the pusher assembly.The pet lock was intact.Offset coil winds were present along the length of the embolization coil.The embolization coil distal tip was measured with a snap gauge (an 0789) and was found to be within specification.Conclusions: evaluation of the returned ruby coil revealed offset coil winds along the length of the catheter.If the introducer sheath is not properly seated in the hub of the microcatheter, resistance may be experienced and damage such as offset coil winds may occur when advancing.Continued attempts to advance the coil forcefully against resistance may cause additional offset coil winds.The customer also reported that the distal tip was too large to fit into the hub of a lantern which could not be confirmed.The coil was able to advance into a demonstration lantern without issue.The distal tip was measured to be within specification.Penumbra coils are 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.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: 9566321
• Report Number: 3005168196-2020-00021
• Device Sequence Number: 2902211
• Product Code: HCG
• UDI-Device Identifier: 00814548013015
• UDI-Public: 00814548013015
• Combination Product (Y/N): Y
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• 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): 12/17/2019
• 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: 11/28/2023
• Device Model Number: RBY2C1240-A
• Device Catalogue Number: RBY2C1240
• Device Lot Number: F66703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Date Report Sent to FDA: 01/01/2005