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

Catalog Number	RBY2C0620-A
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The pet lock was intact on the proximal end of the ruby coil pusher assembly.The pusher assembly was kinked approximately 32.0 and 62.0 cm from the proximal end and fractured approximately 100.0 cm from the proximal end.The segment of the pusher assembly distal to the fracture was not returned for evaluation.Evaluation of the returned device revealed the pusher assembly was fractured.If the ruby coil is forcefully manipulated during insertion into a microcatheter, the pusher assembly may become kinked.If a kinked pusher assembly is further manipulated, it may become fractured.The introducer sheath, embolization coil, distal segment of the pusher assembly, and non-penumbra microcatheter mentioned in the complaint were 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, while the physician was advancing a ruby coil through another manufacturer's microcatheter, the ruby coil pusher assembly became kinked.Therefore, the ruby coil was removed and the procedure was completed using a new ruby coil 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: 5867166
• Report Number: 3005168196-2016-01152
• Device Sequence Number: 11119257
• Product Code: HCG
• UDI-Device Identifier: 00814548012933
• UDI-Public: 00814548012933
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2016

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: 09/09/2023
• Device Catalogue Number: RBY2C0620-A
• Device Lot Number: F65642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2016
• Initial Report FDA Received Date: 08/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1