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

Catalog Number	4002C2457
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	11/20/2018
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 was kinked approximately 82.5 cm from the proximal end.The embolization coil was intact with the distal detachment tip (ddt) of the pusher assembly.The embolization coil had offset coil winds on its proximal end.During functional testing, resistance was encountered while attempting to advance the pc400 through the hub of a demonstration microcatheter and the pc400 could not advance any further.Conclusions: evaluation of the returned pc400 revealed offset coil winds.If the introducer sheath is not aligned properly with the hub of the parent device, resistance may be experienced.If the device is forcefully advanced against resistance, damage such as offset coil winds may occur.These offset coil winds likely contributed to the additional resistance experienced during the procedure and functional test.Further evaluation revealed a kink on the pusher assembly.Based on the returned condition, the kink is likely incidental to the 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 in the splenic artery using penumbra coil 400s (pc400s).During the procedure, the physician was unable to advance a pc400 through the hub of a lantern delivery microcatheter (lantern) and therefore, the pc400 was removed.The procedure was completed using new pc400s and the same lantern.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: 8196934
• Report Number: 3005168196-2018-02513
• Device Sequence Number: 244191
• Product Code: HCG
• UDI-Device Identifier: 00814548010809
• UDI-Public: 00814548010809
• 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
• Report Date (Section B): 11/27/2018
• 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: 03/18/2021
• Device Catalogue Number: 4002C2457
• Device Lot Number: A34022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• 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: 11/27/2018
• Initial Report FDA Received Date: 12/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Date Report Sent to FDA: 01/01/2005