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

Model Number	4002C2457
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2020
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.This report is associated with mfr report number: 3005168196-2020-00165.
Event or Problem Description
The patient was undergoing a coil embolization procedure using penumbra coil 400s (pc400s) and a microcatheter.During the procedure, while advancing the pc400 through the microcatheter the physician experienced resistance and decided to retract the pc400.However upon retraction, the pc400 had unintentionally detached inside the microcatheter.Therefore, the physician removed the microcatheter containing the detached pc400 and then removed the pc400.The physician then reinserted the same microcatheter and attempted to advance another pc400; however, the same issue occurred, and the pc400 unintentionally detached inside the microcatheter.Therefore, the microcatheter containing the detached pc 400 was removed.The procedure was completed using additional pc400s and a new microcatheter.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the middle cerebral artery (mca) using penumbra coil 400s (pc400s) and px slim delivery microcatheter (px slim).During the procedure, while advancing the pc400 through the px slim the physician experienced resistance and decided to retract the pc400.However, upon retraction, the pc400 had unintentionally detached inside the px slim.Therefore, the physician removed the px slim containing the detached pc400 and then flushed out the pc400.The physician then reinserted the same microcatheter and attempted to advance another pc400; however, the same issue occurred, and the pc400 unintentionally detached inside the px slim.Therefore, the px slim containing the detached pc 400 was removed.The procedure was completed using additional pc400s and a new px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the device associated with this report was expected to be returned; however, upon review of the package, it was identified that the subject device was missing.Therefore, without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report numbers: 1.3005168196-2020-00165, 2.3005168196-2020-00264.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9682931
• Report Number: 3005168196-2020-00164
• Device Sequence Number: 3171410
• Product Code: HCG
• UDI-Device Identifier: 00814548010809
• UDI-Public: 00814548010809
• Combination Product (Y/N): Y
• Initial Reporter Country: MX
• 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,Followup
• Report Date (Section B): 01/17/2020
• 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 Model Number: 4002C2457
• Device Catalogue Number: 4002C2457
• Device Lot Number: F89964
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 02/07/2020
• Supplement Report FDA Received Date: 09/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Date Report Sent to FDA: 01/01/2005