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

Catalog Number	RBY4C0406-A
Medical Device Problem Codes	Detachment Of Device Component (1104); Failure to Advance (2524); Physical Resistance (2578); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock on the proximal end of the ruby coil pusher assembly was intact.The pusher assembly was kinked in multiple locations along the hypotube.The distal detachment tip (ddt) of the pusher assembly was fractured off, and the coil was detached from the pusher assembly.The embolization coil was not returned for evaluation.Conclusions: evaluation of the returned ruby coil revealed that the ddt was fractured off the pusher assembly.This type of damage typically occurs due to improper handling during use.If the ruby coil is forcefully withdrawn against resistance, damage such as this may occur.Further evaluation revealed that the returned px slim was kinked in two locations.Furthermore, it was observed that the rotating hemostasis valve (rhv) was overtightened onto the catheter shaft.If the px slim is manipulated through an overtightened rhv, or otherwise forcefully manipulated at an angle, it is likely that it would become kinked.The observed kinks and overtightened rhv likely contributed to the resistance experienced while manipulating the ruby coil, as mentioned in the initial complaint.These devices are 100% visually evaluated during in-process inspection.Penumbra coils are 100% functionally tested during in-process inspection.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: 3005168196-2016-00115.
Event or Problem Description
The patient was undergoing a coil embolization procedure using ruby coils and a px slim delivery microcatheter (px slim).During the procedure, the physician attempted to advance a ruby coil out of the px slim and into the aneurysm; however, the ruby coil became stuck and unintentionally detached inside the px slim.The physician removed the detached ruby coil and the px slim from the patient and completed the procedure using new ruby coils and a new px slim.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: 5411719
• Report Number: 3005168196-2016-00114
• Device Sequence Number: 620902
• Product Code: HCG
• UDI-Device Identifier: 00814548013169
• UDI-Public: 00814548013169
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other
• Report Date (Section B): 01/05/2016

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: 07/26/2023
• Device Catalogue Number: RBY4C0406-A
• Device Lot Number: F65051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2016
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR