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

Catalog Number RBY2C1660

Device Problems Device Damaged Prior to Use (2284); Device Fell (4014)

Patient Problem No Patient Involvement (2645)

Event Date 05/16/2019

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.The reported complaint involves the sterility of a dropped device prior to use in the patient.Sterility of a dropped device cannot be confirmed in the evaluation lab and does not involve manufacturing records; therefore, an investigation will not be performed.

Event Description

During preparation for a coil embolization procedure, a ruby coil was accidentally dropped upon removal from its packaging hoop.The contamination of the ruby coil occurred prior to use and therefore, it was not used in the procedure.The procedure was completed using a new ruby coil.

• 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: 8699722
• MDR Text Key: 148017485
• Report Number: 3005168196-2019-01167
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548019253
• UDI-Public: 00814548019253
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K173614
• 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: 01/01/2005,05/16/2019

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: Health Professional
• Device Catalogue Number: RBY2C1660
• Device Lot Number: C13193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 05/16/2019
• Initial Date FDA Received: 06/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2018
• 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