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

Catalog Number RBY4C0204

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the ruby coil had multiple kinks at approximately 5.0 cm, 26.5 cm, 37.0 cm, and 76.0 cm from the proximal end of the pusher assembly.The device also had multiple bends approximately 8.5 ¿ 11.0 cm and 116.0 ¿ 127.0 cm from the proximal end of the pusher assembly.The introducer sheath was backwards on the pusher assembly.The proximal pet lock was intact.The embolization coil was intact with its pusher assembly.The embolization coil had stretched platinum coil winds on its proximal end.Conclusions: evaluation of the returned ruby coil revealed kinks and bends along the length of the pusher assembly.If the pusher assembly is forcefully manipulated outside the patient body during attempts to retract the coil, the pusher assembly may become kinked.Further evaluation revealed the introducer sheath was on backwards and the embolization coil was damaged.It is likely the returned embolization coil damage, improper orientation of the introducer sheath, and some of the returned kinks were incidental and occurred during packaging for return to penumbra.The lantern identified in the complaint was not returned for evaluation.Penumbra 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.

Event Description

The patient was undergoing a coil embolization procedure in the gastroduodenal artery (gda) using ruby coils.During the procedure, the physician placed a lantern delivery microcatheter (lantern) in the target vessel.While attempting to deploy a ruby coil in the target vessel the microcatheter kicked out of place, therefore, the lantern and ruby coil were removed.Upon removal, the pusher wire on the ruby coil was found to be kinked.The procedure was completed using a new ruby coil with 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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 8044440
• MDR Text Key: 127344913
• Report Number: 3005168196-2018-02202
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548018270
• UDI-Public: 00814548018270
• Combination Product (y/n): Y
• 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: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RBY4C0204
• Device Lot Number: F83867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Is the Reporter a Health Professional?: Yes
• 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: 10/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2018
• 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: 68 YR
• Patient Weight: 91