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

Catalog Number	RBY4C0620-A
Medical Device Problem Codes	Kinked (1339); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2016
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the renal artery to treat an aneurysm in the left kidney, using ruby coils.During the procedure, after advancing the fifth ruby coil in the aneurysm using a px slim delivery microcatheter (px slim), the physician realized that the ruby coil was over-sized and decided to retract it.However, while attempting to retract the ruby coil, the physician experienced resistance and was unable to re-sheath it.The ruby coil was then pulled out of the px slim and upon retraction, it appeared to be kinked.The procedure was completed using a new ruby coil and the same px slim.It should be noted that the physician maintained continuous flush through the rotating hemostasis valve (rhv).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 embolization coil was intact with the pusher assembly; the embolization coil was compressed on the distal end.Conclusion: evaluation of the returned device revealed that the ruby coil¿s embolization coil was compressed on the distal end.This type of damage typically occurs due to improper handling during use.If the device is forcefully withdrawn against resistance, the coil windings may become offset, and the embolization coil may become compressed.The px slim mentioned in the complaint was not returned for evaluation.All 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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5983820
• Report Number: 3005168196-2016-01379
• Device Sequence Number: 1797114
• Product Code: HCG
• UDI-Device Identifier: 00814548013183
• UDI-Public: 00814548013183
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 08/29/2016

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: 04/12/2024
• Device Catalogue Number: RBY4C0620-A
• Device Lot Number: F68920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/28/2016
• Supplement Report FDA Received Date: 11/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR