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

Catalog Number RBY2C1460

Device Problems Failure to Advance (2524); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked in multiple locations.The embolization coil was intact with its pusher assembly and had offset coil winds along its length.Conclusions: evaluation of the returned ruby coil revealed offset coil winds on the embolization coil.If the device is forcefully manipulated against resistance, the coil may become compressed and offset coil winds may result.These offset coil winds may have contributed to additional resistance experienced during the procedure.Further evaluation revealed the ruby coil pusher assembly was kinked in multiple locations.These kinks were likely incidental to the reported failure and may have occurred while packaging the device for return to penumbra.The ruby coil introducer sheath and the lantern identified in the complaint were not returned to penumbra for evaluation.Due to the returned condition of the ruby coil, the root cause of the reported resistance could not be determined.Penumbra coils and catheters 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 splenic artery using ruby coils.During the procedure, while advancing a ruby coil through a lantern delivery microcatheter (lantern), the physician experienced resistance and the ruby coil would not advance; therefore, it was removed.The procedure was completed using another ruby coil 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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7664087
• MDR Text Key: 113326360
• Report Number: 3005168196-2018-01335
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013046
• UDI-Public: 00814548013046
• 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: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: RBY2C1460
• Device Lot Number: F42193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2014
• 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: 56 YR