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

Catalog Number	RBY4C0620
Medical Device Problem Codes	Kinked (1339); Device Handling Problem (3265)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2016-01438, 3005168196-2016-01439, 3005168196-2016-01440, 3005168196-2016-01442.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the renal artery using ruby coils.During the procedure, the physician first placed another manufacturer's sheath and then advanced a lantern delivery microcatheter (lantern) through it.The physician also had a balloon in place to do a balloon-assisted coiling because of the wide neck of the aneurysm.While attempting to advance a ruby coil through the lantern, the physician encountered resistance and was unable to advance the coil.Therefore, the ruby coil was removed and a new ruby coil was opened to continue the procedure.While attempting to advance this second ruby coil through the lantern, the physician experienced resistance and subsequently, the ruby coil pusher assembly became bent.Therefore, the ruby coil was removed and a third ruby coil was opened.After the physician deployed about half of the coil into the aneurysm, some of the loops of the coil began to prolapse into the parent artery.The physician then retracted the ruby coil completely back into the lantern in order to reposition the coil.While attempting to re-advance the coil into the aneurysm, the physician experienced resistance and was unable to advance the coil out of the tip of the lantern.Therefore, the physician removed this third ruby coil and opened a fourth ruby coil.This fourth ruby coil was then successfully deployed and detached into the aneurysm.Next, while attempting to advance a fifth ruby coil out of its introducer sheath and into the lantern, the new technologist inadvertently kinked the ruby coil pusher assembly.Therefore, the ruby coil was removed and a new ruby coil was opened for the procedure.After about fifteen centimeters of the coil was deployed into the aneurysm, some of the coil looped out into the parent artery.The physician then retracted the coil back into the lantern in order to reposition the coil.However, while attempting to re-advance the ruby coil, the physician was unable to advance the coil out of the tip of the lantern.Therefore, the ruby coil was removed and it was noted that the tip of the coil had an angle on it that appeared to be kinked.The physician then did a run and found that the aneurysm had embolized.Therefore, no additional coils were placed and the procedure was considered successfully completed.It should be noted that the physician did not use a rotating hemostasis valve (rhv) and did not maintain a continuous flush during the procedure.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the ruby coil¿s pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 59.0 cm from the proximal end.The embolization coil was intact with the pusher assembly.The embolization coil was damaged on the distal end, and compressed on the proximal end.The outer diameters (ods) of the undamaged section of all embolization coils were measured and found to be within specification.Conclusions: evaluation of the first ruby coil evaluated revealed that the embolization coil¿s proximal end was compressed, and distal tip was damaged.This type of damage typically occurs due to improper handling during use.If the device is forcefully advanced against resistance, the embolization coil may become compressed, and the coil windings may become offset.Evaluation of the second ruby coil revealed that the pusher assembly was kinked.This type of damage typically occurs due to improper handling during use.If the device is forcefully advanced against resistance, damage such a kink may occur.Evaluation of the third ruby coil evaluated revealed that the embolization coil had offset coil windings.This type of damage typically occurs due to improper handling during use.If the device is forcefully retracted against resistance during re-sheathing of the device, damage such as this may occur.Evaluation of the fourth ruby coil revealed that the embolization coil¿s distal tip was damaged and the coil was compressed as observed on the proximal end inside the introducer sheath.This type of damage typically occurs due to improper handling during use.If the device is forcefully manipulated against resistance, the embolization coil may become compressed and the coil windings may become offset.Further evaluation confirmed that the pusher assembly was kinked.If the ruby coil is forcefully advanced against resistance, this type of damage may occur.Evaluation of the fifth ruby coil revealed that the proximal end of the pusher assembly was kinked.This type of damage typically occurs due to improper handling during use.If the device is forcefully manipulated during use, damage such as this may occur.The root cause of the resistance that was experienced during the attempts to advance the ruby coil out of the lantern could not be determined.The ods of the undamaged sections of all embolization coils were measured and found to be within specification.The lantern mentioned in the complaint was not returned for evaluation and, therefore, the root cause of the resistance mentioned in the complaint could not be determined.Penumbra coils and catheters 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.

• Brand Name: RUBY COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6024877
• Report Number: 3005168196-2016-01441
• Device Sequence Number: 18940172
• Product Code: HCG
• UDI-Device Identifier: 00814548013183
• UDI-Public: 00814548013183
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 09/12/2016

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: Radiologic Technologist
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: RBY4C0620
• Device Lot Number: F60896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/12/2016
• Supplement Report FDA Received Date: 12/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR