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

Catalog Number RBY2C0740

Device Problems Bent (1059); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2017

Event Type  malfunction  

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 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
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 6464341
• MDR Text Key: 71921117
• Report Number: 3005168196-2017-00567
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548012964
• UDI-Public: 00814548012964
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: RBY2C0740
• Device Lot Number: F72490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2017
• Initial Date FDA Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1