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

Catalog Number RBY2C0512

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 11/21/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the top peel-away part of the sterile pouch was breached.Adhesive residue was observed where the pouch is sealed.There was no visible damage to the device.Conclusions: evaluation of the returned device confirmed that the top of the sterile pouch was opened.The top and sides of the sterile pouches are sealed by the vendor who supplies them to penumbra.During incoming inspection at penumbra, the pouches are 100% visually inspected.Once the product is loaded into the sterile pouches, the bottom of the pouches are sealed by penumbra.Then, the sterile pouches are once again 100% visually inspected by quality.The root cause of the sterile pouch not being sealed could not be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

During preparation for a coil embolization procedure, it was noticed that the top of the sterile pouch containing a new ruby coil was not sealed upon opening the packaging box.The unsealed sterile package was found prior to use and therefore, the ruby coil was not used in the procedure.The procedure was successfully completed using other ruby coils.

• 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: 7124534
• MDR Text Key: 95814233
• Report Number: 3005168196-2017-02234
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548012896
• UDI-Public: 00814548012896
• 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: Radiologic Technologist
• Type of Report: Initial
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: RBY2C0512
• Device Lot Number: F30320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2012
• 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