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

Catalog Number	4002C0935
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the penumbra coil 400 (pc400) pusher assembly.The embolization coil was detached from the pusher assembly, the stretch resistant wire was fractured, and the pull wire protruded from the distal detachment tip (ddt).Conclusions: evaluation of the returned lantern revealed that the distal tip was ovalized.This damage may have occurred due to forceful manipulation during positioning through tortuous patient anatomy.Further evaluation revealed that the sr wire was fractured, the pull wire protruded from the ddt, and the embolization coil was detached.If the pc400 is forcefully retracted through an ovalized microcatheter, the sr wire may fracture, which will allow the embolization coil to detach from the pusher assembly.The pull wire protruding from the ddt also likely occurred due to forceful retraction of the pc400 through the ovalized lantern.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.This report is associated with mfr report number: 3005168196-2018-00283.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the portal vein using a lantern delivery microcatheter (lantern) and penumbra coil 400's (pc400s).It was noted that the patient's anatomy was slightly tortuous.During the procedure, the physician advanced the lantern towards the target portion of the portal vein, then deployed and detached an initial pod5.While attempting to advance a new pc400 through the lantern, the physician experienced resistance around the middle of the lantern and decided to remove the whole system from the patient.The physician then attempted to advance the pc400 through the lantern outside the patient's body; however, resistance was encountered again.Therefore, the lantern and pc400 were set aside and the procedure was completed using a new lantern and 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: 7246375
• Report Number: 3005168196-2018-00282
• Device Sequence Number: 143436
• Product Code: HCG
• UDI-Device Identifier: 00814548010588
• UDI-Public: 00814548010588
• 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): 01/10/2018

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: 06/30/2023
• Device Catalogue Number: 4002C0935
• Device Lot Number: F64509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2018
• Initial Report FDA Received Date: 02/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1