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

Catalog Number	RBY2C2457
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2018
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the aorta using ruby coils.During the procedure, the physician felt resistance and was unable to advance a ruby coil through a non-penumbra microcatheter.The ruby coil was therefore removed, and 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 intact on the proximal end of the pusher assembly.The ruby coil pusher assembly was kinked approximately 5.0, 25.0, 47.0, 50.0, and 109.0 cm from the proximal end of the pusher.The embolization coil was intact with the pusher assembly and had some offset coils.Coagulated blood was present throughout the embolization coil and along the length of the pusher assembly.Conclusions: evaluation of the returned ruby coil revealed an embolization coil with offset coil winds.The non-penumbra microcatheter was not returned to penumbra for evaluation and the ruby coil was unable to be functionally tested.Therefore, the root cause of the initial resistance and inability to advance the ruby coil could not be determined.Further evaluation revealed blood was present throughout the length of the device.If continuous flush is not used, blood may backflow into the microcatheter and coagulate on the device.If blood coagulates on the device, this may contribute to the experienced resistance.If the device is forcefully advanced against resistance, damage such as kinking and offset coil winds may occur.Further evaluation revealed kinks along the length of the pusher assembly.Based on the return condition and the reported complaint, some of the kinks are likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7454990
• Report Number: 3005168196-2018-00842
• Device Sequence Number: 1373542
• Product Code: HCG
• UDI-Device Identifier: 00814548013084
• UDI-Public: 00814548013084
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2018
• 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: 10/09/2025
• Device Catalogue Number: RBY2C2457
• Device Lot Number: F79936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/29/2018
• Supplement Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 08/24/2018
• 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