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

Model Number	4002C1135
Medical Device Problem Codes	Break (1069); Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11675831
• Report Number: 3005168196-2021-00768
• Device Sequence Number: 3423710
• Product Code: HCG
• UDI-Device Identifier: 00814548010618
• UDI-Public: 00814548010618
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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
• Report Date (Section B): 03/17/2021
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4002C1135
• Device Catalogue Number: 4002C1135
• Device Lot Number: F89326
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 04/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Date Report Sent to FDA: 01/01/2005