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

Catalog Number	RBY2C1660
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/09/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the second ruby coil evaluated had the pet lock intact and was kinked approximately 5.0 and 40.0 cm from the proximal end.Conclusions: the complaint has been evaluated.The complaint indicated that all three ruby coils became kinked by a scrub technician during insertion into a px slim delivery microcatheter.Evaluation of the three ruby coils confirmed their pusher assemblies were kinked.This type of damage typically occurs due to improper handling during use.If the pusher assembly is manipulated forcefully at an angle during insertion into a catheter, damage such as this may occur.Ruby coils are 100% functionally tested during process inspection.The px slim delivery microcatheter mentioned in the complaint was not returned for evaluation.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report numbers: 3005168196-2019-01625; 3005168196-2019-01627.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils.During preparation for the procedure, the pusher wire of a ruby coil became kinked while advancing into a px slim delivery microcatheter.Two additional ruby coils also became kinked while advancing into the px slim.The procedure successfully continued using additional 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: 8923279
• Report Number: 3005168196-2019-01626
• Device Sequence Number: 1903719
• Product Code: HCG
• UDI-Device Identifier: 00814548013053
• UDI-Public: 00814548013053
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/09/2015
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: RBY2C1660
• Device Lot Number: F63543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2015
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2015
• Initial Report FDA Received Date: 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005