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

Model Number	4002C1557
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2020
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: 3005168196-2020-01841.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right middle cerebral artery (mca) using a penumbra coil 400 (pc400) and a px slim delivery microcatheter (px slim).During the procedure, while advancing the pc400 through the px slim and into the target vessel, the physician experienced resistance and subsequently, the pc400 became stuck in the px slim.Therefore, px slim and pc400 were removed.The procedure was completed using another px slim and additional pc400s.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 at approximately 66.0 cm and 69.0 cm from the proximal end.The pusher assembly was fractured at approximately 68.0 cm from the proximal end.The pull wire was retracted from the pusher assembly distal detachment tip (ddt).The embolization coil was detached from the pusher assembly and had offset coil winds.Conclusions: evaluation of the returned px slim revealed proximal kinks.If the device is forcefully manipulated at extreme angles during use, damage such as this may occur.These kinks may have contributed to the reported resistance experienced during the procedure while advancing the pc400 through the px slim.Evaluation of the returned pc400 revealed that the pusher assembly was kinked and fractured, and the embolization coil was detached from the pusher assembly.If the pc400 is forcefully advanced against resistance, the pusher assembly may become kinked and, subsequently, a fracture may occur.If the pusher assembly is fractured and the pull wire is retracted from the ddt, the embolization coil may detach from the pusher assembly.Further evaluation of the device revealed offset coil winds on the embolization coil.This damage was likely incidental to the complaint.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: 3005168196-2020-01841.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10758220
• Report Number: 3005168196-2020-01840
• Device Sequence Number: 3385809
• Product Code: HCG
• UDI-Device Identifier: 00814548010700
• UDI-Public: 00814548010700
• Combination Product (Y/N): Y
• Initial Reporter Country: RS
• PMA/510(K) Number: K120330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2020
• 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: 4002C1557
• Device Catalogue Number: 4002C1557
• Device Lot Number: F86332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 12/16/2020
• 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