MAUDE Adverse Event Report: PENUMBRA, INC. PAC400 COIL; HCG, KRD

Model Number	400PAC35
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the carotid-cavernous fistula using a pac400s, penumbra coil 400 (pc400s), and px slim delivery microcatheter (px slim).During the procedure, the physician placed pc400s and pac400s in the target location using the px slim.Next, after advancing approximately fifty percent of a pac400 into the target location as the final coil, the px slim began to kick back due to the lack of space within the fistula.The physician made multiple attempts to recapture a small segment of the pac400, repositioned the microcatheter, and attempted to redeploy the pac400.However, on the final attempt to reposition the px slim, the physician pulled back on the pusher assembly of the pac400 and noticed the coil had unintentionally detached inside the px slim.Subsequently, the physician used the pusher assembly of the pac400 to push the remaining coil into place.The physician was satisfied with the results and the procedure had ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed on the initial mfr report and is being included on this follow-up #01 mfr report 3005168196-2021-01312: 1.Section d.Box 6.Implant date.Please note that the coil was implanted in the patient and the pusher assembly associated with this complaint was expected to be returned; however, it was disposed of by the hospital and is no longer available for return.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 h3 other text : placeholder.

• Brand Name: PAC400 COIL
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11917983
• Report Number: 3005168196-2021-01210
• Device Sequence Number: 19637118
• Product Code: HCG
• UDI-Device Identifier: 00815948021327
• UDI-Public: 00815948021327
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2021
• 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: 400PAC35
• Device Catalogue Number: 400PAC35
• Device Lot Number: C16056
• 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: 05/04/2021
• Supplement Date Received by Manufacturer: 07/17/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Date Report Sent to FDA: 01/01/2005