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

Model Number 4002C2060

Device Problems Break (1069); Physical Resistance/Sticking (4012); Premature Separation (4045)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2021

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation.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 number: 3005168196-2021-02075.

Event Description

The patient was undergoing a coil embolization procedure in the right internal carotid artery (ica) to treat a carotid cavernous fistula (ccf) using penumbra coil 400 (pc400s), a px slim delivery microcatheter (px slim), and a neuron max 6f 088 long sheath (neuron max).During the procedure, while advancing a pc400 through the px slim, the physician experienced resistance.Next, the physician thought there must be some slack in the px slim and relieved it by pulling the px slim slightly back; however, no slack was observed via fluoroscopy.Subsequently, the pc400 unintentionally detached halfway out the distal end of the px slim with that part of the coil in the target vessel.Therefore, the physician successfully removed part of the detached pc400 using a snare device, and some with the help of aspiration and a stent retriever.It was reported that while removing the detached pc400, the pc400 broke into pieces.Next, the physician advanced another pc400 into the target vessel.While forming the pc400, the physician experienced resistance and subsequently, the pc400 unintentionally detached.It was reported that the physician was unable to remove the detached pc400; however, a string like portion of the pc400 was pulled out of the px slim.The remaining part of the detached pc400 was left in the ccf and was thrombosed.Afterwards, the physician made multiple attempts to remove the detached pc400 using a snare device but was unsuccessful since the coil mass was obstructing access.Consequently, another physician attempted to remove the detached pc400 but was also unsuccessful.Therefore, the detached pc400 was left in situ.The procedure was completed by gaining access through the middle meningeal artery and using non-adhesive liquid embolic agent to close the ccf.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA COIL 400
• Type of Device: 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: 12485674
• MDR Text Key: 271904972
• Report Number: 3005168196-2021-02074
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548010762
• UDI-Public: 00814548010762
• Combination Product (y/n): Y
• Reporter Country Code: IN
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4002C2060
• Device Catalogue Number: 4002C2060
• Device Lot Number: F102343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 09/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR