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	04/11/2016
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 embolization coil was detached from the pusher assembly with a fractured stretch resistant (sr) wire.There was no visible damage to the introducer sheath.The outer diameter (od) of the embolization coil was measured and found to be within specification.Conclusions: evaluation of the returned device revealed the sr wire was fractured and the embolization coil was detached.Sr wire fracture typically occurs due to forceful retraction of the ruby coil against resistance.If the sr wire becomes fractured, the embolization coil will likely detach.The outer diameter (od) of the embolization coil was measured and found to be within specification.Since the embolization coil was detached, the ruby coil could not be functionally tested, and the root cause of the inability to advance the ruby coil out of the introducer sheath could not be determined.The non-penumbra microcatheter mentioned in the complaint was not returned for evaluation.Ruby coils are 100% functionally and visually evaluated 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 was unable to advance a ruby coil out of its orange introducer sheath and into another manufacturer's microcatheter.The ruby coil was removed and the procedure was completed using new ruby coils and the same microcatheter.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: 5648716
• Report Number: 3005168196-2016-00650
• Device Sequence Number: 25278
• Product Code: HCG
• UDI-Device Identifier: 00814548012933
• UDI-Public: 00814548012933
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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: Radiologic Technologist
• Type of Report: Initial
• Report Date (Section B): 04/12/2016

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: 11/30/2021
• Device Catalogue Number: RBY2C0620-A
• Device Lot Number: F39836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2016
• Initial Report FDA Received Date: 05/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR