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

Catalog Number RBY4C0315

Device Problems Component Falling (1105); Contamination (1120)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/12/2015

Event Type  malfunction  

Manufacturer Narrative

The pet lock was intact.The pusher assembly was kinked approximately 8.5 cm from the proximal end.The complaint has been evaluated.The complaint indicated that during the procedure, the ruby coil was dropped on the floor and was not used further.Evaluation of the returned device revealed the pusher assembly was kinked.This type of damage typically occurs due to improper handling during use.If the device is dropped on the floor during use, damage such as this may occur.These devices are 100% visually inspected and functionally tested during process inspection.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 using ruby coils.During the procedure, the ruby coil was dropped on the ground, rendering it unsterile.The procedure continued successfully using a new ruby coil.

Manufacturer Narrative

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

• 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: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 4842314
• MDR Text Key: 13491704
• Report Number: 3005168196-2015-00587
• Device Sequence Number: 1
• Product Code: HCG
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: RBY4C0315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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