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

Catalog Number	4002C1450
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact at the proximal end of the pusher assembly.Bends were present on the pusher assembly approximately 39.0 cm and 103.0 cm from the proximal end.The embolization coil had offset coil winds on its proximal end and was intact with the distal detachment tip (ddt) of the pusher assembly.Evaluation of the returned pc400 revealed offset coil winds on the proximal end of the embolization coil.If the introducer sheath is not seated properly within the hub of the parent catheter, damage such as offset coil winds may occur.The offset coil winds likely contributed to the reported inability to advance the device through the microcatheter.During functional testing, the pc400 was able to advance through the returned lantern with minor resistance.Further evaluation revealed bends on the pusher assembly.These bends were likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.Evaluation of the returned lantern revealed an ovalization.There was no complaint allegation against the lantern and 13 coils were deployed without issue after the complaint pc400.Based on the return condition and the reported complaint the ovalization on the returned lantern is likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right pulmonary artery using penumbra coil 400s (pc400s).During the procedure, the physician attempted to place a pc400 in the target vessel using a lantern delivery microcatheter (lantern); however, resistance was encountered approximately two centimeters through the lantern and the pc400 would not advance further.Therefore, the pc400 was removed.The procedure was completed using additional pc400s, other coils, 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: 8239862
• Report Number: 3005168196-2019-00053
• Device Sequence Number: 1658095
• Product Code: HCG
• UDI-Device Identifier: 00814548010687
• UDI-Public: 00814548010687
• 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): 12/12/2018
• 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: 06/19/2025
• Device Catalogue Number: 4002C1450
• Device Lot Number: F77801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• 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: 12/12/2018
• Initial Report FDA Received Date: 01/11/2019
• 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