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

Catalog Number	4006C0306
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2019
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 major aortopulmonary collateral artery (mapca) using penumbra coil 400 (pc400).During the procedure, the physician successfully placed eight pc400s in the target vessel using a lantern delivery microcatheter (lantern).While attempting to advance a new pc400, the microcatheter kicked out of the target vessel.Therefore, the physician removed the pc400 and repositioned the microcatheter.The physician then attempted to advance the same pc400, however, it became stuck and was unable to advance within its introducer sheath.Therefore, the pc400 was removed.The procedure was completed using three new pc400s and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the penumbra coil 400 (pc400) pusher assembly.The pusher assembly had bends throughout its length from the proximal end.The embolization coil was intact with the pusher assembly distal detachment tip (ddt).Offset coil winds were present throughout the embolization coil.The pusher assembly mid-joint was slightly proximal to the introducer sheath friction lock.The introducer sheath was ovalized approximately 54.0 cm from the proximal end.Conclusions: evaluation of the returned pc400 revealed offset coil winds and an ovalization on the introducer sheath.If the device is forcefully advanced against resistance, damage such as offset coils winds may occur.The offset coil winds and ovalized introducer sheath likely contributed to the inability to re-advance the pc400 out of its introducer sheath during the procedure.During functional testing, the pc400 was advanced out of its introducer sheath with resistance.Resistance was experienced while attempting to advance the pc400 through a demonstration lantern and the pc400 could not advance any further.Further evaluation revealed bends along the pusher assembly.These damages were likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8855740
• Report Number: 3005168196-2019-01486
• Device Sequence Number: 2494707
• Product Code: HCG
• UDI-Device Identifier: 00814548011837
• UDI-Public: 00814548011837
• 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): 07/03/2019
• 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: 07/18/2026
• Device Catalogue Number: 4006C0306
• Device Lot Number: F84757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 08/20/2019
• Initial Report FDA Received Date: 08/02/2019
• Supplement Report FDA Received Date: 08/20/2019
• 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