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

Catalog Number	4004C0820
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2019
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery (sa) using penumbra coil 400s (pc400s).During the procedure, the physician successfully placed multiple ruby coils using a non-penumbra microcatheter.The physician then felt resistance and was unable to advance a pc400 through the middle of the microcatheter.The physician attempted to remove the microcatheter with the pc400 inside and consequently, the pc400 unintentionally detached within the microcatheter.The pc400 was successfully removed, and the procedure was then completed using the same microcatheter and a new pc400.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by the distributor on 04/03/2019: describe event or problem.Results: the pet lock was separated and pull wire was retracted at the proximal end of the pusher assembly.The pull tube was kinked approximately 3.0 cm from the proximal end.The pull wire was retracted into the pusher assembly.The pusher assembly distal detachment tip (ddt) was undamaged.The introducer sheath was ovalized approximately 26.0 cm, 83.5 cm and 84.5 cm from the proximal end.Conclusions: evaluation of the returned pc400 pusher assembly revealed a separated pet lock and retracted pull wire.If the pusher assembly is forcefully mishandled during removal from the microcatheter, the pet lock may become broken and pull wire may be retracted.If the pet lock is broken upon removal of the device and the pull wire is retracted, the embolization coil will likely detach from the pusher assembly ddt.This was likely the cause of the detachment.The embolization coil and non-penumbra microcatheter were not returned for evaluation; therefore, the root cause of the initial resistance experienced while advancing could not be determined.Further evaluation revealed ovalizations along the introducer sheath.These ovalizations were likely incidental to the reported complaint.Penumbra 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 splenic artery (sa) using penumbra coil 400s (pc400s).During the procedure, the physician successfully placed multiple pc400s using a non-penumbra microcatheter.The physician then felt resistance and was unable to advance a pc400 through the middle of the microcatheter.The physician attempted to remove the microcatheter with the pc400 inside and consequently, the pc400 unintentionally detached within the microcatheter.The microcatheter was then removed with the pc400 inside, and the procedure was completed using the same microcatheter 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: 8360010
• Report Number: 3005168196-2019-00311
• Device Sequence Number: 207136
• Product Code: HCG
• UDI-Device Identifier: 00814548010922
• UDI-Public: 00814548010922
• Combination Product (Y/N): Y
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2019
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Expiration Date: 02/19/2025
• Device Catalogue Number: 4004C0820
• Device Lot Number: F74521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 02/21/2019
• Supplement Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Date Report Sent to FDA: 01/01/2005