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

Model Number	4004C0720
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Premature Separation (4045)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2021-00030.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the anterior communicating artery (acom) using penumbra coils 400 (pc400s) and a px slim delivery microcatheter (px slim).During the procedure, while advancing a pc400 out of the px slim, the physician experienced resistance and the pc400 would not advance further.The physician then attempted to pull the pc400 in the px slim and experienced resistance again.Subsequently, the pc400 unintentionally detached inside the px slim.Therefore, the detached pc400 and px slim were removed together.The procedure was completed using other coils and another microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned pc400 confirmed that the embolization coil was detached from the pusher assembly and was within the px slim.Further evaluation revealed that the proximal constraint sphere was within the pusher assembly ddt, the sr wire was fractured, and the embolization coil had offset coil winds.If the pc400 is forcefully retracted against resistance, damage such as this may occur.Further evaluation revealed pusher assembly kinks.This damage may be incidental to the reported complaint.Evaluation of the returned px slim revealed an ovalization on the mid-shaft.If the device is forcefully pinched or gripped during use, damage such as an ovalization may occur.This damage likely contributed to the reported resistance experienced during the procedure.Further evaluation revealed a fracture near the hub.This damage was not mentioned in the reported complaint and was likely incidental.Penumbra coils and catheters 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 number: 3005168196-2021-00030 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: 11129417
• Report Number: 3005168196-2021-00029
• Device Sequence Number: 3247204
• Product Code: HCG
• UDI-Device Identifier: 00814548010915
• UDI-Public: 00814548010915
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• 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
• Report Date (Section B): 12/08/2020
• 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: 4004C0720
• Device Catalogue Number: 4004C0720
• Device Lot Number: F95184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 02/17/2021
• 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