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

Catalog Number	RBY2C0410
Medical Device Problem Codes	Device Contamination with Body Fluid (2317); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2018-00558, 3005168196-2018-00559.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the lumbar artery to treat a type ii endoleak using ruby coils.It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician advanced a lantern delivery microcatheter (lantern) into the target location, and though the physician was using continuous flush, blood entered the introducer sheath of a ruby coil as the technician attempted to advance the ruby coil.The technician felt resistance advancing the ruby coil, and therefore the ruby coil was removed and a new ruby coil was placed.The physician repositioned the lantern and then attempted to place another ruby coil, however the technician felt resistance advancing the ruby coil within its introducer sheath, and therefore the ruby coil was removed.A new ruby coil was then successfully placed.The technician then again felt resistance advancing another ruby coil within its introducer sheath, and the ruby coil was therefore removed.The procedure was then completed using the same lantern, a new ruby coil, a pod5, and a pod packing coil.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The embolization coil was intact with its pusher assembly.Conclusions: evaluation of the first ruby coil identified in the complaint revealed that the device was able to be advanced through a demonstration microcatheter and out of the distal tip without an issue.Evaluation of the second ruby coil identified in the complaint revealed that the sr wire was fractured.If the device is forcefully retracted against resistance, damage such as this may occur.The pusher assembly to this ruby coil was not returned.Evaluation of the third ruby coil identified in the complaint revealed that the introducer sheath had coagulated blood inside.During the functional test, the ruby coil could not be re-sheathed and, therefore, the ruby coil was unable to functionally test for the reported resistance.No other devices associated with the complaint were returned for evaluation.The root cause of the reported resistance for the three subject ruby coils could not be determined.Penumbra coils and catheters are visually 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 numbers: 3005168196-2018-00558, 3005168196-2018-00559.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7337704
• Report Number: 3005168196-2018-00557
• Device Sequence Number: 1030393
• Product Code: HCG
• UDI-Device Identifier: 00814548012841
• UDI-Public: 00814548012841
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 02/12/2018

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: Health Professional
• Device Expiration Date: 12/19/2025
• Device Catalogue Number: RBY2C0410
• Device Lot Number: F81115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Initial Date Received by Manufacturer: 02/12/2018
• Supplement Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 03/14/2018
• Supplement Report FDA Received Date: 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR