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

Catalog Number	RBY2C1240
Medical Device Problem Codes	Detachment Of Device Component (1104); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2018
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.This report is associated with mfr report number: 3005168196-2018-01076.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, the physician felt resistance while advancing a ruby coil within a non-penumbra microcatheter and, therefore, the ruby coil was removed and re-sheathed.The physician then attempted to advance another ruby coil through the microcatheter; however, the physician again felt resistance.While attempted to retract, the ruby coil unintentionally detached within the microcatheter.The physician therefore removed the microcatheter with the ruby coil inside.The physician completed the procedure by advancing additional coils through the diagnostic catheter.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 pusher assembly was kinked in multiple locations.The embolization coil was detached from its pusher assembly and the distal detachment tip (ddt) was fractured off the distal tip.Conclusions: evaluation of the first evaluated ruby coil revealed that the pusher assembly was kinked.If the device is forcefully advanced against resistance, damage such as a kink may occur.During the functional test, resistance was encountered as the kinks in the pusher assembly were being advanced through the demonstration microcatheter; however, the ruby coil was able to be advance completely through the microcatheter and out of the distal tip.The root cause of the reported resistance could not be determined.Evaluation of the second evaluated ruby coil revealed that the ddt was fractured off the pusher assembly.If the device is forcefully retracted against resistance, damage such as the ddt fracturing off the pusher assembly may occur.Further evaluation of the returned ruby coil revealed that the embolization coil was detached from its pusher assembly.If the ddt is fractured off the pusher assembly, the embolization coil will detach from its pusher assembly as the ddt is what keeps the coil intact with the pusher assembly.Further evaluation of the returned device revealed that the pusher assembly was kinked in multiple locations.These kinks were likely incidental to the reported issue and likely occurred during packaging of the device for return to penumbra.Evaluation of the returned non-penumbra microcatheter revealed that the catheter shaft was ovalized in multiple locations.These ovalization may have occurred due to forceful handling during the procedure.The ovalization likely contributed to the reported resistance while advancing the second ruby coil through the non-penumbra microcatheter during the procedure.Evaluation of the returned handle revealed that the device was functional.The handle was functionally tested on the handle fixture and passed within specification.This handle was not complaint related.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.Penumbra handles are visually inspected and 100% functionally tested during incoming inspection by quality.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 number: 3005168196-2018-01076.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7553593
• Report Number: 3005168196-2018-01077
• Device Sequence Number: 16692878
• Product Code: HCG
• UDI-Device Identifier: 00814548013015
• UDI-Public: 00814548013015
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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): 05/01/2018
• 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: 11/18/2025
• Device Catalogue Number: RBY2C1240
• Device Lot Number: F80622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/01/2018
• Supplement Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 09/25/2018
• 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