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

Catalog Number RBY2C1260

Device Problems Detachment Of Device Component (1104); Physical Resistance (2578); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/29/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the ruby coil was stuck inside the lantern.Conclusions: evaluation of the returned devices revealed that the lantern was ovalized and the ruby coil was stuck inside.The ovalization in the lantern typically occurs due to improper handling during use.If the device is forcefully gripped or pinched during insertion, damage such as this may occur.Further evaluation of the returned devices revealed that the ruby coil was stuck inside the lantern and detached from its pusher assembly.If the device is advanced through a damaged catheter, resistance may be experienced and the device may get stuck.Subsequently, if the device is forcefully retracted against resistance, the embolization coil may detach from its pusher assembly.The ruby coil being advance through a damage catheter likely contributed the resistance experience and subsequently, retraction against resistance resulted in the unintentional detachment.A stainless steel mandrel was advanced through the lantern.While advancing the stainless steel mandrel through the lantern, resistance was encountered as the mandrel approached the proximal end of the embolization coil that was stuck inside the lantern and the mandrel could not be advanced any further.The ruby coil was detached and stuck inside the lantern and, therefore, could not be functionally tested.The ruby coil's pusher assembly was not returned for evaluation.Penumbra catheters and coils are visually 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.This report is associated with mfr report number: 3005168196-2018-00211.

Event Description

The patient was undergoing a coil embolization procedure in the right femoral artery using lantern delivery microcatheters (lanterns) and ruby coils.During the procedure, while attempting to advance a ruby coil through a lantern, the physician mentioned resistance.The ruby coil then became stuck and subsequently, unintentionally detached inside the lantern.Therefore, the lantern containing the detached coil was removed.The procedure was completed using a new lantern and a ruby coil.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 (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7219062
• MDR Text Key: 98423707
• Report Number: 3005168196-2018-00212
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013022
• UDI-Public: 00814548013022
• 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
• Type of Report: Initial
• Report Date: 12/29/2017

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: Physician
• Device Catalogue Number: RBY2C1260
• Device Lot Number: F78202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/29/2017
• Initial Date FDA Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2017
• 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
• Patient Age: 80 YR