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

Catalog Number	RBY2C2860
Medical Device Problem Codes	Kinked (1339); Device Handling Problem (3265)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the ruby coil pusher assembly was kinked approximately 5.0 cm from the proximal end.Conclusions: evaluation of the returned ruby coil and podj revealed that their pusher assemblies were kinked.If the device is forcefully advanced against resistance or manipulated at extreme angles outside the patient body, damage such as this may occur.Further evaluation revealed offset coil winds on the returned podj.These offset coil winds were likely incidental to the reported failure and may have occurred during re-sheathing for return to penumbra.Penumbra coils are inspected during in-process inspection and during quality inspection after manufacturing.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 number: 3005168196-2018-01149.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils and pod packing coils (podjs).During the procedure, the physician successfully deployed and detached multiple ruby coils using a lantern delivery microcatheter (lantern).The hospital technical then accidently kinked the pusher assemblies of a ruby coil and a podj while attempting to advance the coils through the lantern and, therefore, the coils was removed.The procedure was completed using additional ruby coils, pod coils, and the same lantern.There was no report of an adverse effect to the patient.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7587070
• Report Number: 3005168196-2018-01148
• Device Sequence Number: 2195520
• Product Code: HCG
• UDI-Device Identifier: 00814548013091
• UDI-Public: 00814548013091
• Combination Product (Y/N): N
• 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): 05/14/2018

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: Physician
• Device Expiration Date: 03/22/2025
• Device Catalogue Number: RBY2C2860
• Device Lot Number: F75166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 06/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR