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

Catalog Number	RBY4C0415
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was broken on the proximal end of the pusher assembly.The pusher assembly was fractured approximately 5.0 cm from the proximal end.The embolization coil was detached from its pusher assembly.Results: the pet lock was broken on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 5.0, 32.5 and 70.0 cm from the proximal end.The embolization coil was intact with its pusher assembly.Conclusions: evaluation of the first returned ruby coil revealed that the embolization coil could be detached using the returned handle.The ruby coil was straightened on the table and the returned handle was attached the proximal end of the pusher assembly and actuated.The embolization coil detached without an issue.The root cause of the ruby coils inability to detach could not be determined.Further evaluation of the returned device revealed that the pusher assembly was kinked.These kinks were likely incidental and may have occurred while packaging the device for return to penumbra.Evaluation of the second returned ruby coil revealed that the pusher assembly was fractured.If the device is forcefully handle during use, damage such as this may occur.Further manipulation of the device after the pusher assembly is fractured may result in the pull wire retracting out of the distal detachment tip (ddt) effectively detaching the embolization coil from the pusher assembly.Evaluation of the returned handle revealed that the device was functional.The handle was tested on the handle fixture for pull force and throw distance and passed without an issue.Then the returned handle was attached to the first ruby coil evaluated and detached the embolization coil without an issue.Penumbra catheters are visually inspected during in-process inspection and during quality inspection after manufacturing.Penumbra handles are 100% functionally tested during incoming inspection by quality.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: 3005168196-2018-00959.
Event or Problem Description
The patient was undergoing a coil embolization procedure treating a gastrointestinal bleed using ruby coils and a ruby coil detachment handle (handle).During the procedure, the physician successfully deployed and detached two ruby coils in the target location using the handle.The physician then was unable to detach a ruby coil using the handle, and therefore the ruby coil was removed.It was also reported that a second ruby coil broke.The procedure was completed using a new ruby coil and the same handle.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Conclusions: evaluation of the first returned ruby coil revealed that the embolization coil could be detached using the returned handle.The ruby coil was straightened on the table and the returned handle was attached the proximal end of the pusher assembly and actuated.The embolization coil detached without an issue.The root cause of the ruby coils inability to detach could not be determined.Further evaluation of the returned device revealed that the pusher assembly was kinked.These kinks were likely incidental and may have occurred while packaging the device for return to penumbra.Evaluation of the second returned ruby coil revealed that the pusher assembly was fractured.If the device is forcefully handle during use, damage such as this may occur.Further manipulation of the device after the pusher assembly is fractured may result in the pull wire retracting out of the distal detachment tip (ddt) effectively detaching the embolization coil from the pusher assembly.Evaluation of the returned handle revealed that the device was functional.The handle was tested on the handle fixture for pull force and throw distance and passed without an issue.Then the returned handle was attached to the first ruby coil evaluated and detached the embolization coil without an issue.Penumbra coils are visually inspected during in-process inspection and during quality inspection after manufacturing.Penumbra handles are 100% functionally tested during incoming inspection by quality.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: 3005168196-2018-00959.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7492441
• Report Number: 3005168196-2018-00960
• Device Sequence Number: 1339773
• Product Code: HCG
• UDI-Device Identifier: 00814548013176
• UDI-Public: 00814548013176
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2018
• 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: Physician
• Device Catalogue Number: RBY4C0415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 10/11/2018
• 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