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

Catalog Number	4002C0620
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2019-00970.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using penumbra coil 400s (pc400s) and a lantern delivery microcatheter (lantern).During the procedure, the physician felt resistance while advancing a pc400 in the lantern and, therefore, the pc400 was removed.The physician was able to smoothly advance a guide wire through the lantern and, therefore, the physician attempted to advance the pc400 again.However, the physician again felt resistance and the pusher assembly of the pc400 became kinked.The lantern and the pc400 were then removed, and the physician found that the tip of the lantern was ovalized.The procedure was then completed using a new lantern and new pc400s.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the returned lantern was ovalized at approximately 134.0 cm from the hub.Conclusions: evaluation of the returned pc400 revealed an embolization coil with compressed and offset coil winds.If the pc400 is forcefully manipulated against resistance, damage such as this may occur.Further evaluation revealed a detached embolization coil.The reported complaint did not mention a detached embolization coil; therefore, this damage was likely incidental to the reported complaint.Evaluation of the returned lantern revealed a distal ovalization.If the device is forcefully gripped or pinched, damage such as a distal ovalization may occur.This damage likely contributed to the reported resistance experienced when advancing the pc400 through the lantern.During functional testing, a demonstration pc400 was attempted to be advanced through the returned lantern and was unable to advance past the ovalized region on the returned 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: 1.(b)(4).H3 other text : placeholder.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8617760
• Report Number: 3005168196-2019-00971
• Device Sequence Number: 3236781
• Product Code: HCG
• UDI-Device Identifier: 00814548010526
• UDI-Public: 00814548010526
• 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): 04/18/2019
• 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: 08/08/2025
• Device Catalogue Number: 4002C0620
• Device Lot Number: F78630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/18/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 08/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005