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

Catalog Number	RBY2C0410-A
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2016
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: 3005168196-2016-00377.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, a ruby coil failed to detach in the aneurysm and was removed from the patient.While advancing a new ruby coil through a lantern delivery microcatheter (lantern), the ruby coil's pusher assembly became kinked and it was removed from the patient.The procedure was completed using a new ruby coil with the same lantern.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Result: the pet lock was intact on the proximal end of the ruby coil pusher assembly; the pusher assembly was fractured approximately 75.0 cm from the proximal end, and the embolization coil was detached from the pusher assembly.Conclusion: evaluation of the returned devices revealed that the pet lock on the proximal end of the first ruby coil pusher assembly was broken.A broken pet lock indicates that an attempt was likely made to detach the embolization coil.In addition the pusher assembly was kinked in multiple locations.These kinks in the pusher assembly likely caused friction between the pull wire and the pusher assembly hypotube.This friction likely prevented the pull wire from retracting during the attempt to detach the embolization coil.When the pusher assembly was removed from the tortuous anatomy, the friction on the pull wire was likely alleviated, resulting in the embolization coil detachment.Further evaluation revealed that the second ruby coil¿s pusher assembly was fractured, and its embolization coil was detached.If the device is forcefully manipulated against resistance, the pusher assembly may become kinked.Additional forceful manipulation of the ruby coil may cause it to fracture at the kink location.A fractured pusher assembly may cause the pull wire to retract, and allow the embolization coil to detach.The lantern mentioned in the complaint was not returned to penumbra for evaluation.Ruby coils are 100% functionally tested during in-process inspection.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: 5536490
• Report Number: 3005168196-2016-00378
• Device Sequence Number: 965865
• Product Code: HCG
• UDI-Device Identifier: 00814548012841
• UDI-Public: 00814548012841
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 03/01/2016

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: 06/30/2022
• Device Catalogue Number: RBY2C0410-A
• Device Lot Number: F44175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2016
• Supplement Report FDA Received Date: 07/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR