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

Catalog Number	4002C1245
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	10/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher had bends approximately 67.0 cm, 101.0 cm and 127.0 cm from the proximal end.The pc400 embolization coil was intact with its pusher assembly.The embolization coil had some offset coil winds on the proximal end of the coil.The introducer sheath was bent approximately 81.0 cm from the proximal end.The introducer sheath was ovalized approximately 93.5 cm from the proximal end.Conclusions: evaluation of the returned pc400 revealed an ovalization on the introducer sheath.If the rhv is over-tightened, the introducer sheath may become ovalized preventing the embolization coil from advancing through its introducer sheath.Further evaluation revealed bends along the length of the pusher assembly.If the device is forcefully advanced while experiencing resistance, damage such as bends may occur.Based on the return condition and the reported complaint, the some of the bends are 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 in the pulmonary artery using penumbra coils 400 (pc400s).During the procedure, the physician placed two non-penumbra coils and one pc400 in the target vessel using a lantern delivery microcatheter (lantern).While attempting to insert another pc400 into the lantern, the physician experienced resistance and the pc400 would not advance within its introducer sheath; therefore, the pc400 was removed.The procedure was completed using two new 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: 8097963
• Report Number: 3005168196-2018-02279
• Device Sequence Number: 2178896
• Product Code: HCG
• UDI-Device Identifier: 00814548010649
• UDI-Public: 00814548010649
• 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): 10/22/2018
• 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: 03/13/2025
• Device Catalogue Number: 4002C1245
• Device Lot Number: F74992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• 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: 10/22/2018
• Initial Report FDA Received Date: 11/21/2018
• 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