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

Catalog Number	RBY2C0740
Medical Device Problem Codes	Bent (1059); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Results: the pusher assembly and introducer sheath of the first ruby coil evaluated were kinked in multiple locations.Conclusions: evaluation of the returned devices revealed the first ruby coil had multiple kinks in the pusher assembly and introducer sheath.This damage was likely incidental and likely occurred during packaging for return.Due to this incidental damage, the locations and root cause of the reported kink could not be determined.Further evaluation revealed the second ruby coil was not detached.Therefore, the root cause of the reported unintentional detachment could not be determined.The microcatheter mentioned in the complaint was not returned for evaluation.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, prior to use, the hospital staff inadvertently bent a ruby coil pusher assembly while removing the ruby coil from its dispenser hoop.Consequently, the ruby coil would not advance into the microcatheter and therefore, it was set aside.While attempting to load a new ruby coil into the microcatheter, the hospital staff noticed that the ruby coil had unintentionally detached from its pusher assembly and therefore, the ruby coil was set aside.The procedure was completed using additional 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: 6464341
• Report Number: 3005168196-2017-00567
• Device Sequence Number: 16288609
• Product Code: HCG
• UDI-Device Identifier: 00814548012964
• UDI-Public: 00814548012964
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 03/09/2017

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: Health Professional
• Device Expiration Date: 10/23/2024
• Device Catalogue Number: RBY2C0740
• Device Lot Number: F72490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2017
• Initial Report FDA Received Date: 04/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1