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

Catalog Number	RBY2C0512
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/21/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7124534
• Report Number: 3005168196-2017-02234
• Device Sequence Number: 16440537
• Product Code: HCG
• UDI-Device Identifier: 00814548012896
• UDI-Public: 00814548012896
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date (Section B): 11/21/2017

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2017
• Initial Report FDA Received Date: 12/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1