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

Catalog Number RBY2C2860

Device Problems Kinked (1339); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the ruby coil pusher assembly was kinked approximately 5.0 cm from the proximal end.Conclusions: evaluation of the returned ruby coil and podj revealed that their pusher assemblies were kinked.If the device is forcefully advanced against resistance or manipulated at extreme angles outside the patient body, damage such as this may occur.Further evaluation revealed offset coil winds on the returned podj.These offset coil winds were likely incidental to the reported failure and may have occurred during re-sheathing 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.This report is associated with mfr report number: 3005168196-2018-01149.

Event Description

The patient was undergoing a coil embolization procedure using ruby coils and pod packing coils (podjs).During the procedure, the physician successfully deployed and detached multiple ruby coils using a lantern delivery microcatheter (lantern).The hospital technical then accidently kinked the pusher assemblies of a ruby coil and a podj while attempting to advance the coils through the lantern and, therefore, the coils was removed.The procedure was completed using additional ruby coils, pod 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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7587070
• MDR Text Key: 110629647
• Report Number: 3005168196-2018-01148
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013091
• UDI-Public: 00814548013091
• 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: Physician
• Type of Report: Initial
• Report Date: 05/14/2018

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: Physician
• Device Catalogue Number: RBY2C2860
• Device Lot Number: F75166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 06/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2017
• 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: 74 YR