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

Catalog Number	RBY2C0415
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	04/01/2019
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 renal artery using ruby coils.During the procedure, the physician successfully implanted a coil into the target vessel using a non-penumbra microcatheter.While advancing the next ruby coil through the distal end of the microcatheter, resistance was experienced and the ruby coil was not able to be advanced out of the microcatheter.The microcatheter and ruby coil were together removed from the patient and the procedure was ended.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed on the follow-up #01 mfr report:3005168196-2019-00906 and is being corrected on this follow-up #02 mfr report: 3005168196-2019-00906.1.Section d.Box10.Device available for evaluation? h3 other text : placeholder.
Additional Manufacturer Narrative
Results: the stretch resistance wire (sr wire) to the embolization coil was fractured and the proximal constraint sphere was missing.The ruby coil was detached from its pusher assembly and, therefore, the ruby coil could not be functionally tested.Conclusions: evaluation of the returned ruby coil revealed that the sr wire was fractured.If the device was forcefully retracted against resistance, damage such as a sr wire fracture may occur.The non-penumbra microcatheter identified in the complaint and the ruby coil pusher assembly were not returned to penumbra for evaluation.Therefore, the root cause of resistance could not be determined.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.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: 8592649
• Report Number: 3005168196-2019-00906
• Device Sequence Number: 16646960
• Product Code: HCG
• UDI-Device Identifier: 00814548012858
• UDI-Public: 00814548012858
• 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,Followup
• Report Date (Section B): 04/09/2019
• 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: 01/10/2025
• Device Catalogue Number: RBY2C0415
• Device Lot Number: F73726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 07/22/2019; 07/22/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 08/20/2019; 08/20/2019
• 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