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

Catalog Number	4004C0935
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	11/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly had bends approximately 34.0 cm, 61.0 cm and 71.0 cm from the proximal end.The pusher assembly was fractured approximately 102.5 cm from the proximal end.The embolization coil was compressed on its proximal end and was detached from the distal detachment tip (ddt) of the pusher assembly.The friction lock was distal to the mid-joint of the pusher assembly.The introducer sheath was ovalized approximately 87.0 - 87.5 cm from the proximal end.Conclusions: evaluation of the returned pc400 revealed an ovalization on the introducer sheath.If the rotating hemostasis valve (rhv) is overtightened on the introducer sheath, the sheath may become ovalized.This likely contributed to the reported inability to advance the pc400 out of the introducer sheath.During functional testing, a demonstration coil was attempted to be advanced through the returned introducer sheath and was unable to advance past the ovalization.Further evaluation of the pc400 revealed kinks and a fracture on the pusher assembly, damage on the embolization coil, and detachment of the embolization coil from the distal detachment tip (ddt) of the pusher assembly.All these damages are 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400s (pc400s).During the procedure, while attempting to advance a pc400 into the microcatheter, the pc400 was stuck and would not advance within its introducer sheath; therefore, it was removed.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: 8191274
• Report Number: 3005168196-2018-02502
• Device Sequence Number: 2640572
• Product Code: HCG
• UDI-Device Identifier: 00814548010953
• UDI-Public: 00814548010953
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/23/2018
• 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: 01/07/2025
• Device Catalogue Number: 4004C0935
• Device Lot Number: F73600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2018
• Initial Report FDA Received Date: 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Date Report Sent to FDA: 01/01/2005