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

Catalog Number RBY4C0315

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2018

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, the physician found that the ruby coil would not deploy into the target vessel.Therefore, the ruby coil was removed.No further details were provided.

Manufacturer Narrative

Results: the pet lock was slightly compressed at the proximal end of the pusher assembly but was intact.The pusher assembly had bends and kinks approximately 5.0 cm, 20.0 cm, 27.0 cm, 51.0 cm, 69.0 cm, 86.0 cm, 102.0 cm and 119.0 cm from the proximal end.The embolization coil was undamaged and intact with the pusher assembly distal detachment tip (ddt).Conclusion: evaluation of the returned ruby coil revealed the proximal pet lock was intact.If the pet lock is not broken, the pull wire could not retract allowing the embolization coil to detach.This may have occurred due to handle being improperly seated on the proximal end of the pusher assembly.During functional testing, a demonstration handle was used and the proximal pet lock was separated and the pull wire was retracted from the ddt.However, the embolization coil did not detach due to dried blood on the proximal constraint sphere.If the pull wire was retracted from the ddt during the procedure, the embolization coil would have likely detached from the pusher assembly.Further evaluation revealed bends and kinks along the pusher assembly.These damages were likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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.Please note that the following sections are being updated based on additional information provided by the sales representative on 01/07/2019: describe event or problem.This report is associated with mfr report number: 1.3005168196-2019-00033.

Event Description

The patient was undergoing a coil embolization procedure using ruby coils and a ruby coil detachment handle (handle).During the procedure, the physician successfully deployed several coils into the target vessel using the handle and a lantern delivery microcatheter (lantern).The physician then reported difficulty detaching another ruby coil using the handle.The ruby coil was therefore removed.The procedure was completed using additional ruby coils and the same lantern.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
• MDR Report Key: 8220246
• MDR Text Key: 132205813
• Report Number: 3005168196-2019-00026
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548018324
• UDI-Public: 00814548018324
• 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: 01/01/2005,12/07/2018

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: RBY4C0315
• Device Lot Number: F83181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 01/04/2019
• Supplement Dates Manufacturer Received: 02/20/2019
• Supplement Dates FDA Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1