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

Catalog Number	RBY2C0630
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2019
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.This report is associated with mfr report numbers: 3005168196-2019-00407; 3005168196-2019-00408.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using pod6s and ruby coils.During the procedure, the physician advanced a pod5 in the target vessel but it was deemed to be small; therefore, it was removed.The physician then attempted to advance a pod6 through a non-penumbra microcatheter but resistance was felt and the pod6 would not advance; therefore, it was removed.The physician then successfully advanced the previously removed pod5 in the microcatheter to check for kinks in the microcatheter.After removing the pod5, the physician attempted to re-advance the pod6 again through the microcatheter; however, the pod6 failed to advance and, therefore, was removed.While attempting to advance another pod6 through the microcatheter, the physician experienced friction and, the pod6 would not advance and was kinked.Therefore, it was removed.Next, the physician advanced a ruby coil in the target vessel, but it was deemed to be large; therefore, it was removed.While attempting to advance another ruby coil through the microcatheter, the ruby coil advanced partly through the microcatheter, then resistance was encountered.Subsequently, the ruby coil stopped advancing and unintentionally detached inside the microcatheter.Therefore, the physician removed the entire system.The procedure was completed using a new microcatheter and additional coils.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.Bends were present along the pusher assembly.The embolization coil stretched resistance wire was fractured.The introducer sheath was not returned with the device.Conclusions: evaluation of the first returned pod6 revealed a functional device.During the functional testing, the embolization coil was able to be advanced through its introducer sheath and the demonstration px slim; resistance was experienced due to the bends on the pusher assembly.The non-penumbra microcatheter identified in the complaint was not returned for evaluation; therefore, the root cause of the reported resistance could not be determined.Further investigation revealed that the pusher assembly had bends along its length.These damages were likely incidental and may have occurred during packaging for return to penumbra.Evaluation of the second returned pod6 confirmed kinks on the pusher assembly.If the device is forcefully advanced against resistance, the pusher assembly may become kinked.The non-penumbra microcatheter identified in the complaint was not returned for evaluation.The root cause of the resistance could not be determined.Further investigation revealed that the pusher assembly was fractured and the embolization coil was detached.These damages were likely incidental and may have occurred during packaging for return to penumbra.Evaluation of the ruby coil revealed that the embolization coil stretch resistant (sr) wire was fractured.If the device is forcefully retracted against resistance, damage such as this may occur.The non-penumbra microcatheter identified in the complaint was not returned for evaluation.The root cause of the resistance could not be determined.Further investigation revealed that the pusher assembly had bends along its length.These damages were likely incidental and may have occurred during packaging for returned to penumbra.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.This report is associated with mfr report numbers: 1.3005168196-2019-00407.2.3005168196-2019-00408.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8384172
• Report Number: 3005168196-2019-00409
• Device Sequence Number: 16625046
• Product Code: HCG
• UDI-Device Identifier: 00814548012940
• UDI-Public: 00814548012940
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 02/01/2019
• 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: 04/04/2024
• Device Catalogue Number: RBY2C0630
• Device Lot Number: F68819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/01/2019
• Supplement Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 04/17/2019
• 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