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

Model Number	4002C3260
Medical Device Problem Code	Failure to Fold (1255)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a basilar tip aneurysm using a penumbra coil 400 (pc400) and a px slim delivery microcatheter (px slim).During the procedure, the physician advanced a pc400 in the target vessel using a px slim; however, the pc400 would not take its intended shape or sit properly.It was reported that the physician believed the pc400 had stretched.Therefore, the pc400 was removed.The procedure was completed using a new pc400 and the same px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 5.0, 26.0, 74.0, and 84.0 cm from the proximal end.The embolization coil was intact with the pusher assembly and had offset coil winds.Results: evaluation of the returned pc400 revealed offset coil winds throughout the length of the embolization coil.If the pc400 is forcefully manipulated against resistance, damage such as offset coil winds may occur.These offset coil winds may have contributed the pc400 not taking shape during the procedure.No other devices associated with the complaint were returned for evaluation, therefore, the root cause of resistance could not be determined.Further evaluation revealed kinks throughout the length of the pusher assembly.These kinks were likely incidental to the reported complaint.The introducer sheath could not be advanced over the proximal kink in the pusher assembly during the functional test, and therefore, the pc400 could not be functionally tested.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.H3 other text : placeholder.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed on the follow-up #01 and is being included on this follow-up #02:(b)(4).1.Section h.Box 2.If follow-up, what type? h3 other text : placeholder.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9826198
• Report Number: 3005168196-2020-00344
• Device Sequence Number: 13794884
• Product Code: HCG
• UDI-Device Identifier: 00814548012001
• UDI-Public: 00814548012001
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• 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,Followup,Followup
• Report Date (Section B): 02/21/2020
• 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: 08/29/2026
• Device Model Number: 4002C3260
• Device Catalogue Number: 4002C3260
• Device Lot Number: F85608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 06/02/2020; 06/02/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 06/06/2020; 06/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Date Report Sent to FDA: 01/01/2005