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

Catalog Number	4002C2260
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a carotid cavernous fistula (ccf) using penumbra coil 400s ((b)(4)), a px slim delivery microcatheter (px slim), a neuron 6f 070 delivery catheter (neuron 070), and a non-penumbra long sheath.During the procedure, after advancing approximately twenty centimeters of a (b)(4) into the fistula, the physician reported that the (b)(4) unintentionally detached inside the px slim.Therefore, the px slim containing the detached (b)(4) was removed from the patient.Next, the physician re-advanced the same px slim into the fistula.While advancing another (b)(4) halfway through the px slim, the coil unintentionally detached inside the px slim.Therefore, the px slim containing the detached (b)(4) was removed from the patient.It was also reported that the physician preferred to use a different catheter and decided to remove the neuron 070 from the procedure.The procedure was completed using a non-penumbra microcatheter, non-penumbra coils, a non-penumbra catheter, the same long sheath, and a liquid embolic agent.There was no report of an adverse effect to the patient.
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.This report is associated with mfr report number: 1.3005168196-2023-00533.

• Brand Name: PENUMBRA COIL 400
• Common Device Name: 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: 18241677
• Report Number: 3005168196-2023-00534
• Device Sequence Number: 20494211
• Product Code: HCG
• UDI-Device Identifier: 00814548019376
• UDI-Public: 814548019376
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K173614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/30/2023
• 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 Catalogue Number: 4002C2260
• Device Lot Number: F00004624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 11/06/2023
• Initial Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005