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

Catalog Number	RBY2C0612-A
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the ruby coil pusher assembly; the coil was intact with the pusher assembly and advanced distally out of the px slim.The outer diameter (od) of the ruby coil was measured and found to be within specification.Conclusions: evaluation of the returned devices revealed both devices were functional.During testing, the ruby coil was introduced through the hub of the same px slim that was returned for evaluation and advanced distally out the distal tip of the microcatheter without an issue.Therefore, the root cause of this complaint cannot be determined.The od of the ruby coil was measured and found to be within specification.The inner diameter (id) of the px slim was measured using a 0.025"stainless steel mandrel and found to be within specification.The ruby coils are 100% functionally tested during in-process inspection.The px slims are 100% visually inspected during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, the physician deployed and detached several ruby coils into the aneurysm using a px slim delivery microcatheter (px slim).While the physician was advancing a new ruby coil through the px slim, the ruby coil advanced about 20 centimeters through the px slim and then stopped advancing.The ruby coil was removed without any issues and the procedure was completed using new ruby coils and the same px slim.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5462020
• Report Number: 3005168196-2016-00224
• Device Sequence Number: 301474
• Product Code: HCG
• UDI-Device Identifier: 00814548012926
• UDI-Public: 00814548012926
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 01/26/2016

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: 10/24/2023
• Device Catalogue Number: RBY2C0612-A
• Device Lot Number: F66157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2016
• Initial Report FDA Received Date: 02/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR