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

Model Number 4002C1135

Device Problems Break (1069); Unraveled Material (1664); Physical Resistance/Sticking (4012)

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

Event Date 03/17/2021

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.

Event Description

The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using penumbra coil 400s (pc400), px slim delivery microcatheter (px slim), and a non-penumbra embolization device.During the procedure, the physician placed a px slim behind the embolization device and placed two pc400s in the aneurysm.While advancing another pc400 as the third coil, the physician experienced resistance inside the aneurysm from the packing density of the previously placed pc400s.The physician then pulled the pc400 in an attempt to remove it; however, the pc400 had unintentionally detached with approximately five centimeters of the pc400 in the aneurysm and the rest of the coil was within the microcatheter.Subsequently, while pulling the pc400, the coil became stretched.Therefore, the physician used a snare device to remove the remaining pc400 out of the microcatheter and aorta; then used aspiration to successfully remove the remaining pc400.The physician decided to end the procedure at this point due to access with the px slim was lost.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: 11675831
• MDR Text Key: 245746079
• Report Number: 3005168196-2021-00768
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548010618
• UDI-Public: 00814548010618
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,03/17/2021

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: 4002C1135
• Device Catalogue Number: 4002C1135
• Device Lot Number: F89326
• 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: 03/17/2021
• Initial Date FDA Received: 04/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2019
• 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: 75 YR