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

Model Number	4002C1040
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2018
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 undamaged.The embolization coil was intact with the pusher assembly.The introducer sheath was ovalized approximately 2.0 cm from the distal tip of the introducer sheath.Conclusions: evaluation of the returned pc400 revealed an ovalized introducer sheath.If the device is retracted out of its packaging hoop at extreme angles or otherwise mishandled during preparation, the introducer sheath may become ovalized.Functional analysis demonstrated that the returned pc400 was successfully able to advance through a demonstration introducer sheath.Penumbra coils are visually 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 balloon-occluded retrograde transfemoral obliteration (brto) procedure using penumbra coils 400 (pc400s).During the procedure, the physician deployed and detached the first pc400 in the target vessel using a non-penumbra microcatheter.While attempting to advance a new pc400 out of introducer sheath and into saline, the physician experienced resistance near the tip of the introducer sheath and the pc400 would not come out; therefore, the pc400 was not used in the procedure.The procedure was completed using three other pc400 and the same microcatheter.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: 7769809
• Report Number: 3005168196-2018-01541
• Device Sequence Number: 11385054
• Product Code: HCG
• UDI-Device Identifier: 00814548010601
• UDI-Public: 00814548010601
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2018
• 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: 07/19/2024
• Device Model Number: 4002C1040
• Device Catalogue Number: 4002C1040
• Device Lot Number: F70752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/12/2018
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 02/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 62
• Date Report Sent to FDA: 01/01/2005