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

Catalog Number	4002C1857
Medical Device Problem Codes	Failure to Advance (2524); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock on the proximal end of the pc400 pusher assembly was intact.The pusher assembly was kinked approximately 68.0 cm from the proximal end.The embolization coil was intact with the pusher assembly, and the distal tip of the pull wire was protruding out of the distal detachment tip (ddt).The outer diameter (od) of the pc400 embolization coil was measured to be within specification.The inner diameter (id) of the introducer sheath was measured to be within specification.Conclusions: evaluation of the returned device revealed that the pc400 embolization coil was offset and kinked in multiple locations.If the pc400 is forcefully advanced against resistance the embolization coil may become offset.The observed damage to the embolization coil likely contributed to friction between the pc400 and the px slim, causing additional resistance during advancement.The od of the pc400 embolization coil and the id of the introducer sheath was measured to be within specification.The px slim mentioned in the complaint was not returned for evaluation and, therefore, the root cause of the initial resistance experienced could not be determined.Further evaluation revealed that the pull wire was protruding out of the ddt, and the pusher assembly was slightly kinked.This damage may occur if excessive force is used in an attempt to advance a pc400 against resistance.All 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal carotid artery (ica)-posterior cerebral artery (pca) using penumbra coil 400 coils (pc400 coils).During the procedure, the physician performed a steam-shaping of a px slim delivery microcatheter (px slim) before advancing it to the right portion of the aneurysm.Although tortuosity was noted in the target vessel, the px slim was able to smoothly advance to the target vessel with no issues noticed.The physician then deployed and detached four pc400 coils into the target vessel using the px slim.While the physician was advancing the fifth pc400 coil into the px slim, the coil became stuck and about ten centimeters of coil would not advance in.The physician removed the pc400 coil successfully and advanced a new pc400 coil through the px slim with no issues.After adjusting the deflection on the previous pc400 coil introducer sheath and confirming no damages to it, the physician made another attempt to advance the pc400 coil into the px slim; however, the coil became stuck at the same location in the px slim.Therefore, the pc400 coil was removed and the procedure was completed using eight new pc400 coils and the same px slim.It should be noted that the physician maintained a continuous flush during the procedure.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: 5851210
• Report Number: 3005168196-2016-01123
• Device Sequence Number: 1356870
• Product Code: HCG
• UDI-Device Identifier: 00814548010748
• UDI-Public: 00814548010748
• 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): 07/07/2016

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: 12/16/2023
• Device Catalogue Number: 4002C1857
• Device Lot Number: F66988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2016
• Initial Report FDA Received Date: 08/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR