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

Catalog Number RBY4C0630

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/04/2014

Event Type  malfunction  

Event Description

Upon removal from the packaging, there was no coil connected to the ruby coil pusher assembly.

Manufacturer Narrative

Conclusion: this device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Manufacturer Narrative

Result: the pet lock was broken.The ruby coil was kinked approximately 0.7 cm, 3.5 cm, 8.0 cm, and 14.0 cm from the proximal end, and 43.0 cm from the distal end.The proximal constraint sphere was still intact with the distal detachment tip (ddt), and the stretch resistant (sr) wire of the coil was fractured.Conclusion: the complaint has been evaluated.The initial complaint indicated the coil was missing from the pusher assembly.Evaluation of the returned device revealed that there were multiple kinks along the length of the ruby coil pusher assembly.This type of damage typically occurs due to improper handling during device preparation or use.Further evaluation revealed that the sr wire was fractured, and the proximal constraint sphere was still intact with the ddt.This damage is also typical of improper handling during preparation or use.If the device was removed from the packaging hoop or manipulated with force at an angle, it is likely that these types of damage would occur.These devices are 100% functionally and visually tested during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: RUBY COIL
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; 1351 harbor bay parkway; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; 1351 harbor bay parkway; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; 1351 harbor bay parkway; alameda, CA 94502 ; 5107483200
• MDR Report Key: 4303015
• MDR Text Key: 5194064
• Report Number: 3005168196-2014-00849
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2014

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: Physician
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: RBY4C0630
• Device Lot Number: F37625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2015
• Initial Date FDA Received: 12/08/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2018
• 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