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

Catalog Number RBY2C1035

Device Problems Bent (1059); Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Date 01/13/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the ruby coil pusher assembly was kinked approximately 5.0 cm from its proximal end.Conclusions: evaluation of the returned ruby coil revealed a kink on the proximal end of the pusher assembly.This damage is likely a result of the technologist inadvertently bending the pusher assembly while removing it from the packaging hoop.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

While preparing a new ruby coil for a coil embolization procedure, the technologist inadvertently bent the ruby coil pusher assembly while removing the coil from its dispenser hoop.The pusher assembly became bent prior to use and therefore, the ruby coil was not used for the procedure.The procedure was completed using five new ruby coils.

• Brand Name: RUBY COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7267030
• MDR Text Key: 100060022
• Report Number: 3005168196-2018-00337
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013008
• UDI-Public: 00814548013008
• 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: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Catalogue Number: RBY2C1035
• Device Lot Number: F70674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2016
• 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