MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD

Catalog Number	4002C0620
Medical Device Problem Codes	Detachment Of Device Component (1104); Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the returned penumbra coil 400 (pc400).The pc400 pusher assembly was fractured approximately 85.0 cm from its proximal end.The pusher assembly was kinked just distal to the fracture at approximately 87.0 cm from the proximal end.The proximal constraint sphere was intact on the embolization coil.There were minor offset coil winds along the length of the embolization coil.Conclusions: evaluation of the returned pc400 revealed a fractured pusher assembly and detached embolization coil.If the pusher assembly fractures, it can allow the pull wire to retract from the distal detachment tip (ddt).This would allow the embolization coil to detach from the pusher assembly.Further evaluation revealed a kink just distal to the pusher assembly fracture.It is likely that this fracture and kink were a result of forcefully gripping the pusher assembly when advancing the pc400 against resistance.Further evaluation revealed minor offset coils winds along the length of the embolization coil.This damage was likely a result of repeated cycling and advancing against resistance.Evaluation of the returned lantern delivery microcatheter (lantern) revealed several ovalizations on the most distal 5.0 cm of the catheter.During functional testing, a demonstration embolization coil was unable to advance pass the distal ovalizations.It was reported that the same lantern was used during the procedure subsequent to the subject pc400 issue.This indicates that the lantern ovalizations were likely incidental and happened post-procedure.The root cause of the initial resistance could not be determined.Penumbra catheters and 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left internal iliac artery using penumbra coil 400's (pc400's).It was noted that the patient's anatomy was mildly tortuous but no calcification, stenosis or constriction observed.During the procedure, while attempting to advance a pc400 through a lantern delivery microcatheter (lantern), the physician experienced resistance right after the insertion of the pc400.The physician then retracted the pc400 back into its introducer sheath and made another attempt to advance the coil into the lantern; however, resistance was encountered again and the pc400 was removed.Upon attempting to advance the pc400 out of its introducer sheath outside the patient¿s body, the physician noticed that the pc400 had detached.Therefore, the procedure was completed using three new pc400's and the same lantern.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7095560
• Report Number: 3005168196-2017-02158
• Device Sequence Number: 1235548
• Product Code: HCG
• UDI-Device Identifier: 00814548010526
• UDI-Public: 00814548010526
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/09/2017

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: 09/13/2024
• Device Catalogue Number: 4002C0620
• Device Lot Number: F71599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1