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

Catalog Number RBY4C0860

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2018

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

During preparation for a coil embolization procedure, a hospital staff noticed that the ruby coil pusher assembly was bent before they opened the packaging.The damaged ruby coil was found prior to use and, therefore, was not used in the procedure.The procedure was completed using 17 additional ruby coils.

Manufacturer Narrative

Results: the pet lock was damaged and pull tube was retracted approximately 2.0 cm from the proximal end of the hypotube.The embolization coil was detached from the pusher assembly and the coil was intact with the constraint ball.The embolization coil was undamaged.Conclusion: evaluation of the returned ruby coil revealed a retracted pull tube and a detached embolization coil.The pet lock secures the position of the pull tube and prevents the embolization coil from prematurely detaching.If the pull tube is retracted, the embolization coil will detach from the pusher assembly.The root cause of the damaged pet lock may occur if the pull tube becomes bent during removal from the packaging.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.

• Brand Name: RUBY COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8076183
• MDR Text Key: 127342749
• Report Number: 3005168196-2018-02251
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548018393
• UDI-Public: 00814548018393
• Combination Product (y/n): Y
• PMA/PMN Number: K173614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RBY4C0860
• Device Lot Number: F84574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1