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

Catalog Number	RBY2C0620-A
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2016
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: 3005168196-2016-00261.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, the physician was unable to advance two ruby coils through the px slim delivery microcatheter (px slim).The physician flushed and repositioned the px slim; however, the ruby coils were still unable to advance through it and were removed.The procedure was completed using two new ruby coils and the same px slim.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 first ruby coil¿s pusher assembly.The pusher assembly was bent approximately 14.0 and 47.0 cm from the proximal end.There was dried blood inside the introducer sheath that could not be flushed out.The embolization coil was intact with the pusher assembly.The outer diameter (od) of the embolization coil was measured and found to be within specification.Conclusions: evaluation of the returned devices revealed the pusher assemblies were bent and the embolization coil of the second ruby coil was kinked.This damage likely occurred due to forceful advancement of the ruby coils against resistance.Further evaluation revealed the introducer sheaths were full of dried blood, which prevented the ruby coils from being functionally evaluated.Both ruby coils¿ ods were measured and found to be within specification.Since the ruby coils could not be functionally evaluated due to dried blood and the px slim delivery microcatheter (px slim) mentioned in the complaint was not returned for evaluation, the root cause of the complaint could not be determined.Ruby coils are 100% functionally evaluated 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: 5472069
• Report Number: 3005168196-2016-00260
• Device Sequence Number: 256137
• Product Code: HCG
• UDI-Device Identifier: 00814548012933
• UDI-Public: 00814548012933
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2016

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: 09/20/2023
• Device Catalogue Number: RBY2C0620-A
• Device Lot Number: F65774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2016
• Supplement Report FDA Received Date: 04/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1