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

Catalog Number RBY4C0415-A

Device Problem Component Falling (1105)

Patient Problem No Patient Involvement (2645)

Event Date 01/27/2016

Event Type  malfunction  

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the ruby coil pusher assembly; the coil was intact with the pusher assembly; the introducer sheath was not returned for evaluation.Conclusions: evaluation of the returned device revealed no visible damage to the ruby coil.The ruby coil's introducer sheath was not returned for evaluation.Ruby coils are 100% functionally tested during in-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 physician deployed and detached six ruby coils into the aneurysm using a lantern delivery microcatheter (lantern).While a new ruby coil was being loaded into the lantern, the ruby coil unintentionally fell off the table.The dropped ruby coil was not used for the procedure and did not enter the patient's body.The procedure was completed using two new ruby coils.

• 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: 5464496
• MDR Text Key: 39207045
• Report Number: 3005168196-2016-00238
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548013176
• UDI-Public: 00814548013176
• 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: 01/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/26/2023
• Device Catalogue Number: RBY4C0415-A
• Device Lot Number: F65076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2015
• 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