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

Catalog Number	4006C0408
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	03/26/2018
Type of Reportable Event	Malfunction
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.An unknown substance was found on the outside of the pusher assembly.Conclusions: evaluation of the returned device revealed that the pc400 pusher assembly had an unknown substance on the outside of the pusher hypotube.The pc400 pusher assembly was advanced within its introducer sheath.However, resistance was encountered as an unknown substance on the outside of the pusher prevented the introducer sheath from being retracted from the pusher.The substance was removed by the penumbra investigator, the sheath was reloaded on its pusher assembly, and the pc400 was advanced through a demonstration microcatheter and out of the distal tip without an issue.The unknown substance on the pusher assembly likely caused the pusher to get stuck within the introducer sheath friction lock and prevented the introducer sheath from being removed during the procedure.The lantern referred to in the complaint was not returned to penumbra for evaluation.Penumbra catheters and coils 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400s (pc400s).During the procedure, the physician successfully deployed and detached a pod coil and two pc400s using a lantern delivery microcatheter (lantern).The physician then advanced another pc400 into the lantern, and attempted to remove the introducer sheath from the proximal end of the pusher assembly of the pc400.However, the pusher assembly was stuck within the friction lock on the introducer sheath and could not be removed.The physician therefore removed the lantern with the pc400 inside, and then reinserted the same lantern.The procedure was completed using a new pc400.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: 7456811
• Report Number: 3005168196-2018-00830
• Device Sequence Number: 806676
• Product Code: HCG
• UDI-Device Identifier: 00814548011905
• UDI-Public: 00814548011905
• 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): 03/26/2018

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: Physician
• Device Expiration Date: 11/26/2024
• Device Catalogue Number: 4006C0408
• Device Lot Number: F72274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 04/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1