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

Catalog Number	RBY4C0202
Medical Device Problem Codes	Retraction Problem (1536); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2018
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.During the procedure, the physician was unable to advance or retract a ruby coil smoothly within the non-penumbra microcatheter and, therefore, the ruby coil was removed.The procedure was completed using a new ruby coil and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was still intact.The pusher assembly was bent approximately 12.0 cm and 153.0 cm from the proximal end of the pusher assembly.The embolization coil was intact with the pusher assembly.The embolization coil had offset coil winds.The introducer sheath was not returned with the pusher assembly for evaluation.There was minor resistance while advancing the ruby coil assembly through a demonstration microcatheter using a demonstration sheath.The ruby coil was advanced out of the distal tip of the microcatheter.Conclusions: evaluation of the returned ruby coil revealed some offset coil winds on its length.These offset coil winds may have been due to forcefully retracting or advancing the embolization coil against resistance.If the embolization coil is mishandled during preparation, offset coil winds may occur also.During the functional test, the ruby coil was able to be advanced through the length of a demonstration microcatheter with some resistance.The offset coil winds likely contributed to the resistance experienced during the procedure and functional test.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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7664057
• Report Number: 3005168196-2018-01340
• Device Sequence Number: 11388215
• Product Code: HCG
• UDI-Device Identifier: 00814548013121
• UDI-Public: 00814548013121
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2018
• 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: Physician
• Device Expiration Date: 03/01/2025
• Device Catalogue Number: RBY4C0202
• Device Lot Number: F74744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/08/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 07/05/2018
• Supplement Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Date Report Sent to FDA: 01/01/2005