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

Model Number	4002C1235
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2021
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 numbers: 3005168196-2021-02471, 3005168196-2021-02472.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the basilar artery using a px slim delivery microcatheter (px slim) and penumbra coil 400s (pc400s).It was noted that the patient anatomy was tortuous.During the procedure, while advancing a pc400 into the px slim, the pc400 became stuck.Therefore, the pc400 was removed.Next, while advancing a new pc400 into the px slim, the same issue occurred, the pc400 became stuck.Therefore, the pc400 and the px slim were removed.The procedure was completed using new pc400s and a new px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned px slim revealed, ovalizations on the distal shaft.If the device is forcefully pinched or gripped during use, damage such as this may occur.Manipulation of the device within the reported tortuosity of the patient¿s anatomy may have contributed to the ovalization.This damage likely, contributed to resistance, while advancing the two subject pc400¿s, during the procedure.Further evaluation revealed, that the pusher assembly distal detachment tip (ddt) and embolization coil for second pc400 was within the catheter.And was unable to be removed.This damage was incidental to the reported complaint and may have occurred, after removal from the procedure.Evaluation of the first returned pc400 revealed, offset coil winds and pusher assembly kinks.This damage was likely, due to advancement through the damaged px slim if the device forcefully advanced against resistance, damage such as this may occur.Resistance was experienced, during re-sheathing and subsequent, advancement through a demonstration px slim, due to the offset coil winds and pusher assembly kinks.Evaluation of the second returned pc400 revealed, that the pusher assembly ddt was fractured, and the embolization coil was detached within the px slim.This damage is likely a result, of advancement through the damaged px slim.If the pc400 is forcefully manipulated against resistance, damage such as this may occur.Due to the return damage, the device could not be functionally tested.Further evaluation revealed, a pusher assembly kink.This damage was likely, incidental to the reported complaint.Penumbra catheters and 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.This report is associated with mfr report numbers: 1.3005168196-2021-02471.2.3005168196-2021-02472.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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 12741068
• Report Number: 3005168196-2021-02473
• Device Sequence Number: 4126784
• Product Code: HCG
• UDI-Device Identifier: 00814548010632
• UDI-Public: 00814548010632
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2022
• 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: 4002C1235
• Device Catalogue Number: 4002C1235
• Device Lot Number: F103427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Is the Reporter a Health Professional?: Yes
• 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: 10/07/2021
• Supplement Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005